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Trial record 19 of 47 for:    DESIPRAMINE

A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine

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: NCT01358968
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: LY2603618
Drug: Desipramine
Drug: Pemetrexed
Drug: Gemcitabine
Enrollment 20
Recruitment Details  
Pre-assignment Details This was a nonrandomized, open-label, fixed-sequence, 2-period study followed by a continued access phase.
Arm/Group Title Desipramine (Period 1) LY2603618 + Desipramine (Period 2) LY2603618 + Gemcitabine (Continued Access) LY2603618 + Pemetrexed (Continued Access)
Hide Arm/Group Description Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1. Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.

Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.

Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

Period Title: Period 1
Started 20 0 0 0
Received at Least 1 Dose of Study Drug 20 0 0 0
Completed 20 0 0 0
Not Completed 0 0 0 0
Period Title: Period 2
Started 0 20 0 0
Received at Least 1 Dose of Study Drug 0 19 0 0
Completed 0 19 0 0
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Period Title: Continued Access Phase
Started 0 0 12 7
Received at Least 1 Dose of Study Drug 0 0 12 7
Completed 0 0 0 0
Not Completed 0 0 12 7
Reason Not Completed
Progression of Disease             0             0             8             4
Protocol Violation             0             0             0             2
Withdrawal by Subject             0             0             3             0
Death             0             0             1             1
Arm/Group Title All Participants
Hide Arm/Group Description

Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1. Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

Participants may have received additional doses of LY2603618 in combination as follows: 1000 milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase OR 500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.

Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
58.3  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
11
  55.0%
Male
9
  45.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
20
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  35.0%
White
12
  60.0%
More than one race
1
   5.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Plasma Pharmacokinetics of LY2603618: the Maximum Concentration of LY2603618 in the Plasma (Cmax)
Hide Description [Not Specified]
Time Frame Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2603618 and had pharmacokinetic data collected to calculate the Cmax of LY2603618 in Period 2.
Arm/Group Title LY2603618
Hide Arm/Group Description:

Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.

Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

Overall Number of Participants Analyzed 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
5950
(39%)
2.Primary Outcome
Title Plasma Pharmacokinetics of Desipramine: the Maximum Concentration of Desipramine in the Plasma (Cmax)
Hide Description [Not Specified]
Time Frame Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received desipramine and had pharmacokinetic data collected to calculate the Cmax of desipramine in Periods 1 and 2.
Arm/Group Title Desipramine
Hide Arm/Group Description:

Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.

Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

Overall Number of Participants Analyzed 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
Period 1 Number Analyzed 20 participants
21.2
(67%)
Period 2 Number Analyzed 19 participants
22.8
(62%)
3.Primary Outcome
Title Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
Hide Description [Not Specified]
Time Frame Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2603618 and had pharmacokinetic data collected to calculate the AUC(0-∞) of LY2603618 in Period 2.
Arm/Group Title LY2603618
Hide Arm/Group Description:

Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.

Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

Overall Number of Participants Analyzed 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
53700
(55%)
4.Primary Outcome
Title Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
Hide Description [Not Specified]
Time Frame Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received desipramine and had pharmacokinetic data collected to calculate the AUC(0-∞) of desipramine in Periods 1 and 2.
Arm/Group Title Desipramine
Hide Arm/Group Description:

Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.

Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

Overall Number of Participants Analyzed 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
Period 1 Number Analyzed 20 participants
655
(84%)
Period 2 Number Analyzed 19 participants
687
(80%)
5.Primary Outcome
Title Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of LY2603618 [AUC(0-tlast)]
Hide Description [Not Specified]
Time Frame Period 2 only: Predose 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received LY2603618 and had pharmacokinetic data collected to calculate the AUC(0-tlast) of LY2603618 in Period 2.
Arm/Group Title LY2603618
Hide Arm/Group Description:

Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.

Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

Overall Number of Participants Analyzed 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
53000
(52%)
6.Primary Outcome
Title Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of Desipramine [AUC(0-tlast)]
Hide Description [Not Specified]
Time Frame Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received desipramine and had pharmacokinetic data collected to calculate AUC(0-tlast) of desipramine in Periods 1 and 2.
Arm/Group Title Desipramine
Hide Arm/Group Description:

Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.

Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

Overall Number of Participants Analyzed 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter (ng*h/mL)
Period 1 Number Analyzed 20 participants
619
(76%)
Period 2 Number Analyzed 19 participants
653
(72%)
7.Secondary Outcome
Title Number of Participants With a Tumor Response
Hide Description Tumor response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). CR is the disappearance of all target and non-target lesions and PR is a ≥30% decrease in sum of longest diameter of target lesions. Number of participants with a tumor response is the total number of participants with CR or PR.
Time Frame Baseline to study completion up to 11 cycles of 21-day cycles
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had tumor response measured during continued access phase.
Arm/Group Title LY2603618 + Gemcitabine (Continued Access) LY2603618 + Pemetrexed (Continued Access)
Hide Arm/Group Description:

1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.

Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.

Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

Overall Number of Participants Analyzed 9 6
Measure Type: Count of Participants
Unit of Measure: Participants
1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desipramine (Period 1) LY2603618 + Desipramine (Period 2) LY2603618 + Gemcitabine (Continued Access) LY2603618 + Pemetrexed (Continued Access)
Hide Arm/Group Description Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1. Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.

1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.

Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.

Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

All-Cause Mortality
Desipramine (Period 1) LY2603618 + Desipramine (Period 2) LY2603618 + Gemcitabine (Continued Access) LY2603618 + Pemetrexed (Continued Access)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Desipramine (Period 1) LY2603618 + Desipramine (Period 2) LY2603618 + Gemcitabine (Continued Access) LY2603618 + Pemetrexed (Continued Access)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/19 (5.26%)      4/12 (33.33%)      2/7 (28.57%)    
Blood and lymphatic system disorders         
Anaemia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Neutropenia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders         
Gastrointestinal haemorrhage  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Intestinal obstruction  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations         
Arthritis infective  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Cellulitis  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Device related infection  1  0/20 (0.00%)  0 1/19 (5.26%)  1 0/12 (0.00%)  0 1/7 (14.29%)  1
Sepsis  1 [1]  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Injury, poisoning and procedural complications         
Procedural complication  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Vascular disorders         
Embolism  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
Event resulted in death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desipramine (Period 1) LY2603618 + Desipramine (Period 2) LY2603618 + Gemcitabine (Continued Access) LY2603618 + Pemetrexed (Continued Access)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/20 (40.00%)      12/19 (63.16%)      12/12 (100.00%)      7/7 (100.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/20 (0.00%)  0 1/19 (5.26%)  1 6/12 (50.00%)  6 2/7 (28.57%)  2
Neutropenia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 8/12 (66.67%)  11 1/7 (14.29%)  2
Thrombocytopenia  1  0/20 (0.00%)  0 1/19 (5.26%)  1 4/12 (33.33%)  6 2/7 (28.57%)  2
Cardiac disorders         
Palpitations  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Tachycardia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  2 0/7 (0.00%)  0
Gastrointestinal disorders         
Abdominal distension  1  0/20 (0.00%)  0 1/19 (5.26%)  2 0/12 (0.00%)  0 0/7 (0.00%)  0
Abdominal pain  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  1
Abdominal pain upper  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Constipation  1  0/20 (0.00%)  0 0/19 (0.00%)  0 4/12 (33.33%)  6 1/7 (14.29%)  1
Diarrhoea  1  0/20 (0.00%)  0 2/19 (10.53%)  2 6/12 (50.00%)  8 3/7 (42.86%)  4
Dry mouth  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Dyspepsia  1  1/20 (5.00%)  1 0/19 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  1
Flatulence  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Gastritis  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Intestinal obstruction  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Nausea  1  1/20 (5.00%)  1 5/19 (26.32%)  6 5/12 (41.67%)  7 5/7 (71.43%)  9
Oesophagitis  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Paraesthesia oral  1  1/20 (5.00%)  1 0/19 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0
Stomatitis  1  0/20 (0.00%)  0 0/19 (0.00%)  0 3/12 (25.00%)  3 2/7 (28.57%)  2
Vomiting  1  1/20 (5.00%)  1 3/19 (15.79%)  4 5/12 (41.67%)  12 3/7 (42.86%)  5
General disorders         
Chest discomfort  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Chills  1  1/20 (5.00%)  1 0/19 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  1
Disease progression  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  2 0/7 (0.00%)  0
Fatigue  1  0/20 (0.00%)  0 2/19 (10.53%)  2 9/12 (75.00%)  11 5/7 (71.43%)  7
Injection site reaction  1  0/20 (0.00%)  0 4/19 (21.05%)  4 1/12 (8.33%)  1 0/7 (0.00%)  0
Oedema peripheral  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 2/7 (28.57%)  3
Pain  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  1
Pyrexia  1  1/20 (5.00%)  1 1/19 (5.26%)  1 4/12 (33.33%)  9 1/7 (14.29%)  1
Infections and infestations         
Helicobacter infection  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Infection  1  0/20 (0.00%)  0 1/19 (5.26%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0
Lung infection  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Pneumonia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 2/12 (16.67%)  2 0/7 (0.00%)  0
Sinusitis  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  2
Upper respiratory tract infection  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Urinary tract infection  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod bite  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Fall  1  1/20 (5.00%)  1 1/19 (5.26%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0
Infusion related reaction  1  0/20 (0.00%)  0 4/19 (21.05%)  4 1/12 (8.33%)  1 0/7 (0.00%)  0
Upper limb fracture  1  0/20 (0.00%)  0 1/19 (5.26%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/20 (0.00%)  0 2/19 (10.53%)  2 4/12 (33.33%)  4 0/7 (0.00%)  0
Aspartate aminotransferase increased  1  2/20 (10.00%)  2 0/19 (0.00%)  0 4/12 (33.33%)  4 0/7 (0.00%)  0
Blood bilirubin increased  1  1/20 (5.00%)  1 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Blood creatinine increased  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
International normalised ratio increased  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Weight decreased  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 2/7 (28.57%)  2
Weight increased  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Metabolism and nutrition disorders         
Decreased appetite  1  0/20 (0.00%)  0 1/19 (5.26%)  1 2/12 (16.67%)  2 3/7 (42.86%)  3
Dehydration  1  0/20 (0.00%)  0 1/19 (5.26%)  1 2/12 (16.67%)  2 0/7 (0.00%)  0
Hyperglycaemia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 2/7 (28.57%)  2
Hyperkalaemia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Hypokalaemia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 3/12 (25.00%)  5 2/7 (28.57%)  4
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 2/12 (16.67%)  2 1/7 (14.29%)  1
Back pain  1  0/20 (0.00%)  0 0/19 (0.00%)  0 2/12 (16.67%)  2 1/7 (14.29%)  1
Myalgia  1  0/20 (0.00%)  0 1/19 (5.26%)  1 1/12 (8.33%)  1 1/7 (14.29%)  1
Osteonecrosis of jaw  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Pain in extremity  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Pain in jaw  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders         
Dizziness  1  0/20 (0.00%)  0 1/19 (5.26%)  1 1/12 (8.33%)  1 1/7 (14.29%)  2
Dysgeusia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 2/7 (28.57%)  2
Headache  1  1/20 (5.00%)  1 1/19 (5.26%)  1 0/12 (0.00%)  0 1/7 (14.29%)  1
Lethargy  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  1
Paraesthesia  1  1/20 (5.00%)  1 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Syncope  1  0/20 (0.00%)  0 1/19 (5.26%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0
Tremor  1  0/20 (0.00%)  0 1/19 (5.26%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0
Psychiatric disorders         
Anxiety  1  0/20 (0.00%)  0 1/19 (5.26%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0
Confusional state  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Depression  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Reproductive system and breast disorders         
Oedema genital  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/20 (0.00%)  0 0/19 (0.00%)  0 2/12 (16.67%)  2 0/7 (0.00%)  0
Dyspnoea  1  0/20 (0.00%)  0 1/19 (5.26%)  1 1/12 (8.33%)  1 1/7 (14.29%)  1
Hiccups  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  2
Laryngeal inflammation  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Oropharyngeal pain  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Paranasal sinus hypersecretion  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Pulmonary oedema  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Wheezing  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Dermatitis acneiform  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Dry skin  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Hyperhidrosis  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Rash maculo-papular  1  0/20 (0.00%)  0 0/19 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0
Skin hyperpigmentation  1  0/20 (0.00%)  0 0/19 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1
Vascular disorders         
Hypotension  1  0/20 (0.00%)  0 0/19 (0.00%)  0 2/12 (16.67%)  2 1/7 (14.29%)  2
Phlebitis  1  0/20 (0.00%)  0 1/19 (5.26%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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: NCT01358968     History of Changes
Other Study ID Numbers: 13526
I2I-MC-JMMI ( Other Identifier: Eli Lilly and Company )
First Submitted: May 20, 2011
First Posted: May 24, 2011
Results First Submitted: February 17, 2018
Results First Posted: October 25, 2018
Last Update Posted: October 25, 2018