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A Study of Baricitinib and Rifampicin 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: NCT01910311
Recruitment Status : Completed
First Posted : July 29, 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: Rifampicin
Enrollment 18
Recruitment Details  
Pre-assignment Details This was an open-label, fixed-sequence, 2-period study conducted in healthy participants to compare the single dose pharmacokinetics (PK) of baricitinib when given alone and when coadministered with rifampicin.
Arm/Group Title Baricitinib Then Baricitinib and Rifampicin
Hide Arm/Group Description

Period 1: 10-milligram (mg) dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.

Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally once daily (QD) on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.

Period Title: Period 1 (Days 1-2)
Started 18
Received Baricitinib 18
Completed 18
Not Completed 0
Period Title: Period 2 (Days 3-32)
Started 18
Received Baricitinib 18
Received At Least 1 Dose of Rifampicin 18
Completed 18
Not Completed 0
Arm/Group Title Baricitinib Then Baricitinib and Rifampicin
Hide Arm/Group Description

Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.

Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
40.9  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
18
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
16
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 18 participants
18
1.Primary Outcome
Title PK: Maximum Concentration (Cmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.
Arm/Group Title Baricitinib Baricitinib and Rifampicin
Hide Arm/Group Description:
Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
96.1
(22%)
101
(28%)
2.Primary Outcome
Title PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib
Hide Description [Not Specified]
Time Frame Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.
Arm/Group Title Baricitinib Baricitinib and Rifampicin
Hide Arm/Group Description:
Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with a coadministration of 10-mg dose of baricitinib on Day 10.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
634
(19%)
416
(20%)
3.Primary Outcome
Title PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and who had evaluable PK data.
Arm/Group Title Baricitinib Baricitinib and Rifampicin
Hide Arm/Group Description:
Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
Overall Number of Participants Analyzed 18 18
Median (Full Range)
Unit of Measure: hours (h)
1.00
(0.50 to 2.00)
1.00
(0.50 to 1.00)
Time Frame Baseline through study completion (up to Day 32)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib Rifampicin Baricitinib and Rifampicin
Hide Arm/Group Description

A 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.

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

A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 9.

AEs are reported postdose on Day 3 through predose on Day 10.

A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 10 and 11, with coadministration of a 10-mg dose of baricitinib on Day 10.

AEs are reported postdose on Day 10 up to Day 32.

All-Cause Mortality
Baricitinib Rifampicin Baricitinib and Rifampicin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Baricitinib Rifampicin Baricitinib and Rifampicin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baricitinib Rifampicin Baricitinib and Rifampicin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/18 (16.67%)      3/18 (16.67%)      5/18 (27.78%)    
Gastrointestinal disorders       
Abdominal pain upper  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Flatulence  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Gingival bleeding  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Nausea  1  1/18 (5.56%)  1 0/18 (0.00%)  0 2/18 (11.11%)  2
Vomiting  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  2
General disorders       
Chest discomfort  1  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Fatigue  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Thirst  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Infections and infestations       
Nasopharyngitis  1  1/18 (5.56%)  1 0/18 (0.00%)  0 2/18 (11.11%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Back pain  1  0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
Nervous system disorders       
Headache  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Psychiatric disorders       
Mood swings  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Terminal insomnia  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Renal and urinary disorders       
Chromaturia  1  0/18 (0.00%)  0 1/18 (5.56%)  3 0/18 (0.00%)  0
Pollakiuria  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders       
Acne  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Hyperhidrosis  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
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: NCT01910311    
Other Study ID Numbers: 14608
I4V-MC-JAGK ( Other Identifier: Eli Lilly and Company )
First Submitted: July 25, 2013
First Posted: July 29, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017