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Trial record 28 of 62 for:    Baricitinib

A Study of Baricitinib and Probenecid in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01937026
Recruitment Status : Completed
First Posted : September 9, 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: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Baricitinib
Drug: Probenecid
Enrollment 18
Recruitment Details  
Pre-assignment Details This was an open-label, 2-period, fixed-sequence study.
Arm/Group Title Baricitinib
Hide Arm/Group Description

4 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.

1000 mg probenecid tablet administered orally, twice daily (BID), on Days 3 through 7 in Period 2.

Period Title: Period 1 (Day 1 Through Predose Day 3)
Started 18
Received Baricitinib 18
Completed 18
Not Completed 0
Period Title: Period 2 (At Dosing Day 3 Through Day 8)
Started 18
Received Baricitinib 18
Received Probenecid on Days 3 Through 7 18
Completed 18
Not Completed 0
Arm/Group Title Baricitinib
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4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.

1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2.

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
37.3  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
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
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
 100.0%
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 Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate Cmax of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Probenecid
Hide Arm/Group Description:
4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.

4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.

1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2.

Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
36.2
(22%)
37.3
(20%)
2.Primary Outcome
Title PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Probenecid
Hide Arm/Group Description:
4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.

4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.

1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2.

Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
236
(22%)
480
(14%)
Time Frame Baseline through study completion (up to Day 18).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib Probenecid Baricitinib + Probenecid
Hide Arm/Group Description

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

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

1000 mg probenecid tablet administered orally, BID, on Days 3 through 4 in Period 2.

Adverse events are reported from postdose on Day 3 through predose on Day 5.

4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.

1000 mg probenecid tablet administered orally, BID, on Days 5 through 7 in Period 2.

Adverse events are reported from postdose on Day 5 up to Day 18.

All-Cause Mortality
Baricitinib Probenecid Baricitinib + Probenecid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baricitinib Probenecid Baricitinib + Probenecid
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%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baricitinib Probenecid Baricitinib + Probenecid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/18 (16.67%)      3/18 (16.67%)      8/18 (44.44%)    
Eye disorders       
Ocular hyperaemia  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders       
Abdominal pain upper  1  0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
Constipation  1  0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
General disorders       
Catheter site pain  1  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Fatigue  1  2/18 (11.11%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
Influenza like illness  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Pain  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Infections and infestations       
Oral herpes  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
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 0/18 (0.00%)  0 1/18 (5.56%)  1
Pain in extremity  1  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Nervous system disorders       
Dizziness  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Headache  1  1/18 (5.56%)  1 1/18 (5.56%)  1 6/18 (33.33%)  6
Renal and urinary disorders       
Urine odour abnormal  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Increased upper airway secretion  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Nasal congestion  1  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders       
Night sweats  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: NCT01937026     History of Changes
Other Study ID Numbers: 14604
I4V-MC-JAGG ( Other Identifier: Eli Lilly and Company )
First Submitted: September 3, 2013
First Posted: September 9, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017