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Trial record 15 of 62 for:    Baricitinib

A Study of Baricitinib and Omeprazole in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01925144
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Baricitinib
Drug: Omeprazole
Enrollment 30
Recruitment Details  
Pre-assignment Details This was an open-label, 2-period, fixed-sequence study.
Arm/Group Title Baricitinib + Omeprazole
Hide Arm/Group Description

10 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.

40 mg omeprazole capsule administered orally, once daily (QD), for 8 days (Days 3 through 10) in Period 2.

Period Title: Period 1 (Day 1 Through Predose Day 3)
Started 30
Received Baricitinib 30
Completed 30
Not Completed 0
Period Title: Period 2 (At Dosing Day 3 Through Day12)
Started 30
Received Baricitinib 30
Received 8 Doses of Omeprazole 30
Completed 30
Not Completed 0
Arm/Group Title Baricitinib + Omeprazole
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10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.

40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
44.1  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
8
  26.7%
Male
22
  73.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
30
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 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
0
   0.0%
White
29
  96.7%
More than one race
1
   3.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 30 participants
30
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Cmax of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Omeprazole
Hide Arm/Group Description:
10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.

10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.

40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2.

Overall Number of Participants Analyzed 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
99.2
(32%)
76.8
(25%)
2.Primary Outcome
Title PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Tmax of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Omeprazole
Hide Arm/Group Description:
10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.

10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.

40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2.

Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: hours
1.00
(0.50 to 3.00)
2.00
(0.75 to 6.00)
3.Primary Outcome
Title PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Omeprazole
Hide Arm/Group Description:
10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.

10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.

40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2.

Overall Number of Participants Analyzed 30 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
663
(23%)
712
(23%)
Time Frame Baseline through study completion (up to Day 24).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib Omeprazole Baricitinib + Omeprazole
Hide Arm/Group Description

10 mg baricitinib tablet administered orally once, on Day 1 in Period 1.

Adverse events are reported from baseline through predose on Day 3.

40 mg omeprazole capsule administered orally, QD, on Days 3 through 9 in Period 2.

Adverse events are reported from postdose on Day 3 through predose on Day 10.

10 mg baricitinib tablet administered orally once with 40 mg omeprazole capsule orally once, on Day 10 in Period 2.

Adverse events are reported from postdose on Day 10 up to Day 24.

All-Cause Mortality
Baricitinib Omeprazole Baricitinib + Omeprazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baricitinib Omeprazole Baricitinib + Omeprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baricitinib Omeprazole Baricitinib + Omeprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/30 (16.67%)      8/30 (26.67%)      7/30 (23.33%)    
Gastrointestinal disorders       
Abdominal pain upper  1  0/30 (0.00%)  0 3/30 (10.00%)  3 0/30 (0.00%)  0
Diarrhoea  1  0/30 (0.00%)  0 4/30 (13.33%)  4 2/30 (6.67%)  2
Flatulence  1  1/30 (3.33%)  1 2/30 (6.67%)  2 0/30 (0.00%)  0
Nausea  1  2/30 (6.67%)  2 1/30 (3.33%)  1 0/30 (0.00%)  0
Nervous system disorders       
Headache  1  4/30 (13.33%)  5 3/30 (10.00%)  3 6/30 (20.00%)  6
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: NCT01925144     History of Changes
Other Study ID Numbers: 14603
I4V-MC-JAGF ( Other Identifier: Eli Lilly and Company )
First Submitted: August 15, 2013
First Posted: August 19, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017