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Trial record 35 of 36 for:    AMINOCAPROIC ACID

A Study of LY3127760 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968070
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: LY3127760
Drug: Celecoxib
Drug: Placebo
Enrollment 80
Recruitment Details  
Pre-assignment Details Part 1 was a single-ascending dose, 2-cohort, 3-period, alternating-group dose-escalation study (cohorts 1-2) and Part 2 of the study was a multiple-ascending dose, 4-cohort, parallel-group, dose-escalation study (cohorts 3-6). Replacement participants received interventions intended for those participants whom discontinued early.
Arm/Group Title Cohort 1 Sequence 1 Cohort 1 Sequence 2 Cohort 1 Sequence 3 Cohort 2 Sequence 1 Cohort 2 Sequence 2 Cohort 2 Sequence 3 Cohort 3 LY3127760 60mg Cohort 3 Placebo Cohort 3 Celecoxib 400mg Cohort 4 LY3127760 200mg Cohort 4 Placebo Cohort 4 Celcoxib 400mg Cohort 5 LY3127760 20mg Cohort 5 Placebo Cohort 5 Celecoxib 400mg Cohort 6 LY3127760 600mg Cohort 6 Placebo Cohort 6 Celecoxib 400mg
Hide Arm/Group Description

Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;

Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;

Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;

Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;

Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;

Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;

Participants received 60mg LY3127760 capsules orally once daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily. Participants received 200mg LY3127760 capsules orally once daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily. Participants received 20mg LY3127760 capsules orally once daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily. Participants received 300mg LY3127760 capsules orally twice daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily.
Period Title: Period 1
Started 4 4 4 4 4 4 10 2 2 9 2 2 9 2 2 9 2 2
Completed 4 3 4 2 3 4 8 2 2 9 2 1 9 2 2 8 2 2
Not Completed 0 1 0 2 1 0 2 0 0 0 0 1 0 0 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0             1             0             0             0             0             0             0             0             0             1             0             0
Protocol Violation             0             0             0             1             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Adverse Event             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0
Physician Decision             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Period Title: Period 2
Started 4 4 [1] 4 4 [2] 3 4 0 [3] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3]
Completed 4 4 4 4 2 4 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0
[1]
1 participant was added to replace the participant who discontinued the period 1.
[2]
2 participants were added to replace the 2 participants who discontinued the period 1.
[3]
Part 2 (Cohorts 3 to 6) was planned only for one period.
Period Title: Period 3
Started 4 4 4 4 3 4 0 0 0 0 0 0 0 0 0 0 0 0
Completed 4 4 4 4 3 4 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Cohort 1 Sequence 1 Cohort 1 Sequence 2 Cohort 1 Sequence 3 Cohort 2 Sequence 1 Cohort 2 Sequence 2 Cohort 2 Sequence 3 Cohort 3 LY3127760 60mg Cohort 3 Placebo Cohort 3 Celecoxib 400mg Cohort 4 LY3127760 200mg Cohort 4 Placebo Cohort 4 Celcoxib 400mg Cohort 5 LY3127760 20mg Cohort 5 Placebo Cohort 5 Celecoxib 400mg Cohort 6 LY3127760 300mg Cohort 6 Placebo Cohort 6 Celecoxib 400mg Total
Hide Arm/Group Description

Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;

Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;

Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;

Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;

Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;

Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.

Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;

Participants received 60mg LY3127760 capsules orally once daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily. Participants received 200mg LY3127760 capsules orally once daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily. Participants received 20mg LY3127760 capsules orally once daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily. Participants received 300mg LY3127760 capsules orally twice daily. Participants received placebo capsules orally once daily. Participants received 400mg Celecoxib capsules orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 4 5 4 6 4 4 10 2 2 9 2 2 9 2 2 9 2 2 80
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 4 participants 6 participants 4 participants 4 participants 10 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 80 participants
<=18 years 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Between 18 and 65 years 4 5 4 6 4 4 10 2 2 9 2 2 9 2 2 9 2 2 80
>=65 years 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 4 participants 6 participants 4 participants 4 participants 10 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 80 participants
Female 3 2 2 2 2 0 4 1 0 1 0 2 0 1 0 1 1 0 22
Male 1 3 2 4 2 4 6 1 2 8 2 0 9 1 2 8 1 2 58
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 4 participants 6 participants 4 participants 4 participants 10 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 80 participants
Hispanic or Latino 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Hispanic or Latino 4 5 4 6 4 4 10 2 2 9 2 2 9 2 2 9 2 2 80
Unknown or Not Reported 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 4 participants 6 participants 4 participants 4 participants 10 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 80 participants
American Indian or Alaska Native 0 0 1 0 1 1 0 0 0 1 0 0 1 0 0 0 0 0 5
Asian 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Black or African American 1 0 2 0 2 1 3 1 1 2 1 1 4 2 1 5 0 1 28
White 3 5 1 6 1 2 7 1 1 6 1 1 4 0 1 4 2 1 47
More than one race 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 4 participants 6 participants 4 participants 4 participants 10 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 9 participants 2 participants 2 participants 80 participants
4 5 4 6 4 4 10 2 2 9 2 2 9 2 2 9 2 2 80
1.Primary Outcome
Title Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Hide Description Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Time Frame Baseline to Study Completion (Up To Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Part 1: Placebo Part 1: 20 mg LY3127760 Part 1: 60 mg LY3127760 Part 1: 200 mg LY3127760 Part 1: 600 mg LY3127760 Part 1: 600 mg LY3127760 (Fasted) Part 1: 900 mg LY3127760 Part 2: Placebo Part 2: 20 mg LY3127760 Part 2: 60 mg LY3127760 Part 2: 200 mg LY3127760 Part 2: 300 mg LY3127760 Part 2: 400 mg Celecoxib
Hide Arm/Group Description:
Placebo, Single Dose Administered PO
20 mg LY3127760 Single Dose Administered PO
60 mg LY3127760 Single Dose Administered PO
200 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO During Fasted State
900 mg LY3127760 Single Dose Administered PO
Placebo administered PO, once a day (QD), for 28 days.
20 mg LY3127760 administered PO, QD, for 28 days.
60 mg LY3127760 administered PO, QD, for 28 days.
200 mg LY3127760 administered PO, QD, for 28 days.
300 mg LY3127760 administered PO, twice daily (BID), for 28 days.
Celecoxib administered PO, QD, for 28 days.
Overall Number of Participants Analyzed 19 8 8 8 8 8 8 8 9 10 9 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0 0 0 0 0 0 0
2.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760
Hide Description [Not Specified]
Time Frame Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable AUC data.
Arm/Group Title Part 1: 20 mg LY3127760 Part 1: 60 mg LY3127760 Part 1: 200 mg LY3127760 Part 1: 600 mg LY3127760 Part 1: 600 mg LY3127760 (Fasted) Part 1: 900 mg LY3127760
Hide Arm/Group Description:
20 mg LY3127760 Single Dose Administered PO
60 mg LY3127760 Single Dose Administered PO
200 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO During a Fasted State
900 mg LY3127760 Single Dose Administered PO
Overall Number of Participants Analyzed 8 6 6 8 8 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms•hour/milliliter (ng•hr/mL)
NA [1] 
(NA%)
3010
(42%)
17200
(9%)
40000
(17%)
47400
(20%)
71900
(20%)
[1]
Not calculated because multiple concentrations were below the detection limit of the assay
3.Secondary Outcome
Title PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760
Hide Description [Not Specified]
Time Frame Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Cmax data.
Arm/Group Title Part 1: 20 mg LY3127760 Part 1: 60 mg LY3127760 Part 1: 200 mg LY3127760 Part 1: 600 mg LY3127760 Part 1: 600 mg LY3127760 (Fasted) Part 1: 900 mg LY3127760
Hide Arm/Group Description:
20 mg LY3127760 Single Dose Administered PO
60 mg LY3127760 Single Dose Administered PO
200 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO During a Fasted State
900 mg LY3127760 Single Dose Administered PO
Overall Number of Participants Analyzed 8 8 8 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
264
(41%)
890
(19%)
3880
(33%)
10300
(37%)
18900
(40%)
21600
(27%)
4.Secondary Outcome
Title PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760
Hide Description [Not Specified]
Time Frame Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Tmax data.
Arm/Group Title Part 1: 20 mg LY3127760 Part 1: 60 mg LY3127760 Part 1: 200 mg LY3127760 Part 1: 600 mg LY3127760 Part 1: 600 mg LY3127760 (Fasted) Part 1: 900 mg LY3127760
Hide Arm/Group Description:
20 mg LY3127760 Single Dose Administered PO
60 mg LY3127760 Single Dose Administered PO
200 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO
600 mg LY3127760 Single Dose Administered PO During a Fasted State
900 mg LY3127760 Single Dose Administered PO
Overall Number of Participants Analyzed 8 8 8 8 8 8
Median (Full Range)
Unit of Measure: Hour
2.00
(1.00 to 4.00)
2.00
(1.00 to 4.02)
2.00
(0.25 to 4.00)
2.00
(2.00 to 4.00)
1.00
(0.52 to 2.00)
1.50
(1.00 to 2.00)
5.Secondary Outcome
Title PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760
Hide Description AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.
Time Frame Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable AUC data.
Arm/Group Title Part 2: 20 mg LY3127760 Part 2: 60 mg LY3127760 Part 2: 200 mg LY3127760 Part 2: 300 mg LY3127760
Hide Arm/Group Description:
20 mg LY3127760 Administered QD PO, Day 1-28
60 mg LY3127760 Administered QD PO, Day 1-28
200 mg LY3127760 Administered QD PO, Day 1-28
300 mg LY3127760 Administered BID PO, Day 1-28
Overall Number of Participants Analyzed 9 8 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng•hr/ml
1020
(20%)
4350
(50%)
11300
(23%)
19700
(15%)
6.Secondary Outcome
Title PK: Cmax of Multiple Doses LY3127760
Hide Description [Not Specified]
Time Frame Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Cmax data.
Arm/Group Title Part 2: 20 mg LY3127760 Part 2: 60 mg LY3127760 Part 2: 200 mg LY3127760 Part 2: 300 mg LY3127760
Hide Arm/Group Description:
20 mg LY3127760 Administered QD PO, Day 1-28
60 mg LY3127760 Administered QD PO, Day 1-28
200 mg LY3127760 Administered QD PO, Day 1-28
300 mg LY3127760 Administered BID PO, Day 1-28
Overall Number of Participants Analyzed 9 8 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
301
(19%)
1210
(53%)
3650
(27%)
6170
(22%)
7.Secondary Outcome
Title PK: Tmax of Multiple Doses LY3127760
Hide Description [Not Specified]
Time Frame Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Tmax data.
Arm/Group Title Part 2: 20 mg LY3127760 Part 2: 60 mg LY3127760 Part 2: 200 mg LY3127760 Part 2: 300 mg LY3127760
Hide Arm/Group Description:
20 mg LY3127760 Administered QD PO, Day 1-28
60 mg LY3127760 Administered QD PO, Day 1-28
200 mg LY3127760 Administered QD PO, Day 1-28
300 mg LY3127760 Administered BID PO, Day 1-28
Overall Number of Participants Analyzed 9 8 9 8
Median (Full Range)
Unit of Measure: hour
2.00
(1.00 to 4.00)
1.65
(1.00 to 4.00)
2.00
(1.00 to 2.02)
2.00
(1.00 to 2.00)
Time Frame [Not Specified]
Adverse Event Reporting Description Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
 
Arm/Group Title Placebo (Part 1) 20 mg LY3127760 (Part 1) 60 mg LY3127760 (Part 1) 200 mg LY3127760 (Part 1) 600 mg LY3127760 (Part 1) 600 mg LY3127760 (Fasted) (Part 1) 900 mg LY3127760 (Part 1) Placebo (Part 2) 20 mg LY3127760 (Part 2) 60 mg LY3127760 (Part 2) 200 mg LY3127760 (Part 2) 300 mg LY3127760 (Part 2) 400 mg Celecoxib (Part 2)
Hide Arm/Group Description Placebo, Single Dose Administered PO 20 mg LY3127760 Single Dose Administered PO 60 mg LY3127760 Single Dose Administered PO 200 mg LY3127760 Single Dose Administered PO 600 mg LY3127760 Single Dose Administered PO 600 mg LY3127760 Single Dose Administered PO During Fasted State 900 mg LY3127760 Single Dose Administered PO Placebo, Administered QD PO, Day 1-28 20 mg LY3127760 Administered QD PO, Day 1-28 60 mg LY3127760 Administered QD PO, Day 1-28 200 mg LY3127760 Administered QD PO, Day 1-28 300 mg LY3127760 Administered BID PO, Day 1-28 400 mg celecoxib Administered QD PO, Day 1-28
All-Cause Mortality
Placebo (Part 1) 20 mg LY3127760 (Part 1) 60 mg LY3127760 (Part 1) 200 mg LY3127760 (Part 1) 600 mg LY3127760 (Part 1) 600 mg LY3127760 (Fasted) (Part 1) 900 mg LY3127760 (Part 1) Placebo (Part 2) 20 mg LY3127760 (Part 2) 60 mg LY3127760 (Part 2) 200 mg LY3127760 (Part 2) 300 mg LY3127760 (Part 2) 400 mg Celecoxib (Part 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Part 1) 20 mg LY3127760 (Part 1) 60 mg LY3127760 (Part 1) 200 mg LY3127760 (Part 1) 600 mg LY3127760 (Part 1) 600 mg LY3127760 (Fasted) (Part 1) 900 mg LY3127760 (Part 1) Placebo (Part 2) 20 mg LY3127760 (Part 2) 60 mg LY3127760 (Part 2) 200 mg LY3127760 (Part 2) 300 mg LY3127760 (Part 2) 400 mg Celecoxib (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/9 (0.00%)      0/10 (0.00%)      0/9 (0.00%)      0/9 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Part 1) 20 mg LY3127760 (Part 1) 60 mg LY3127760 (Part 1) 200 mg LY3127760 (Part 1) 600 mg LY3127760 (Part 1) 600 mg LY3127760 (Fasted) (Part 1) 900 mg LY3127760 (Part 1) Placebo (Part 2) 20 mg LY3127760 (Part 2) 60 mg LY3127760 (Part 2) 200 mg LY3127760 (Part 2) 300 mg LY3127760 (Part 2) 400 mg Celecoxib (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      2/8 (25.00%)      1/8 (12.50%)      1/8 (12.50%)      3/8 (37.50%)      1/8 (12.50%)      2/8 (25.00%)      2/8 (25.00%)      4/9 (44.44%)      5/10 (50.00%)      4/9 (44.44%)      6/9 (66.67%)      3/8 (37.50%)    
Cardiac disorders                           
Palpitations  1  0/19 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Eye disorders                           
Vision blurred  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Gastrointestinal disorders                           
Abdominal pain  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 1/10 (10.00%)  1 0/9 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0
Abdominal pain lower  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Abdominal pain upper  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1
Aphthous stomatitis  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Constipation  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 1/9 (11.11%)  1 0/10 (0.00%)  0 2/9 (22.22%)  3 1/9 (11.11%)  1 0/8 (0.00%)  0
Diarrhoea  1  1/19 (5.26%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Dyspepsia  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1
Nausea  1  1/19 (5.26%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 2/10 (20.00%)  2 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Toothache  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Vomiting  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 2/10 (20.00%)  2 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
General disorders                           
Chills  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Fatigue  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Oedema peripheral  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Pain  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations                           
Gastroenteritis  1  1/19 (5.26%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Otitis media  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Injury, poisoning and procedural complications                           
Excoriation  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Laceration  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders                           
Arthralgia  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 1/9 (11.11%)  2 0/8 (0.00%)  0
Back pain  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 1/9 (11.11%)  1 0/8 (0.00%)  0
Flank pain  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders                           
Dizziness  1  0/19 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Dysgeusia  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 2/10 (20.00%)  2 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Headache  1  2/19 (10.53%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 1/9 (11.11%)  1 2/10 (20.00%)  4 1/9 (11.11%)  1 1/9 (11.11%)  1 2/8 (25.00%)  2
Presyncope  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Psychiatric disorders                           
Abnormal dreams  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders                           
Dermatitis  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0
Hyperhidrosis  1  2/19 (10.53%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Pruritus  1  0/19 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Rash maculo-papular  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
Vascular disorders                           
Flushing  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01968070     History of Changes
Other Study ID Numbers: 15181
I7A-MC-EACA ( Other Identifier: Eli Lilly and Company )
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: September 27, 2017
Results First Posted: June 7, 2019
Last Update Posted: June 7, 2019