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Trial record 31 of 62 for:    Baricitinib

A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01924299
Recruitment Status : Completed
First Posted : August 16, 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: Ketoconazole
Drug: Fluconazole
Enrollment 36
Recruitment Details  
Pre-assignment Details This was an open-label, 2-period, fixed-sequence study. Period 1 was from Day 1 through Day 2. Period 2 was from Day 3 through Day 9 for baricitinib + ketoconazole (Group A) and Day 3 through Day 10 for baricitinib + fluconazole (Group B).
Arm/Group Title Baricitinib + Ketoconazole (Group A) Baricitinib + Fluconazole (Group B)
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10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.

400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2.

10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.

400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.

Period Title: Period 1
Started 18 18
Received Baricitinib 18 18
Completed 18 18
Not Completed 0 0
Period Title: Period 2
Started 18 18
Received at Least 1 Dose of Study Drug 18 18
Received Baricitinib 17 17
Completed 17 17
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             0             1
Arm/Group Title Baricitinib + Ketoconazole (Group A) Baricitinib + Fluconazole (Group B) Total
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10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.

400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.

10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.

400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.

Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
42.3  (15.0) 42.7  (13.7) 42.5  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
2
  11.1%
6
  33.3%
8
  22.2%
Male
16
  88.9%
12
  66.7%
28
  77.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
18
 100.0%
18
 100.0%
36
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.6%
1
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.6%
0
   0.0%
1
   2.8%
White
16
  88.9%
16
  88.9%
32
  88.9%
More than one race
1
   5.6%
1
   5.6%
2
   5.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 18 participants 18 participants 36 participants
18 18 36
1.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
Hide Description [Not Specified]
Time Frame Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 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 + ketoconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.
Arm/Group Title Baricitinib (Group A) Baricitinib + Ketoconazole (Group A)
Hide Arm/Group Description:
10 mg baricitinib administered orally once on Day 1 of Period 1.
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
Overall Number of Participants Analyzed 18 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
720
(23%)
868
(24%)
2.Primary Outcome
Title PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
Hide Description [Not Specified]
Time Frame Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 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 + fluconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.
Arm/Group Title Baricitinib (Group B) Baricitinib + Fluconazole (Group B)
Hide Arm/Group Description:
10 mg baricitinib administered orally once on Day 1 of Period 1.
10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
Overall Number of Participants Analyzed 18 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
698
(24%)
851
(24%)
3.Primary Outcome
Title PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
Hide Description [Not Specified]
Time Frame Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 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 + ketoconazole in Period 2) and had PK data to calculate Cmax of baricitinib.
Arm/Group Title Baricitinib (Group A) Baricitinib + Ketoconazole (Group A)
Hide Arm/Group Description:
10 mg baricitinib administered orally once on Day 1 of Period 1.
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
Overall Number of Participants Analyzed 18 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
106
(27%)
115
(32%)
4.Primary Outcome
Title PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
Hide Description [Not Specified]
Time Frame Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 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 + fluconazole in Period 2) and had PK data to calculate Cmax of baricitinib.
Arm/Group Title Baricitinib (Group B) Baricitinib + Fluconazole (Group B)
Hide Arm/Group Description:
10 mg baricitinib administered orally once on Day 1 of Period 1.
10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
Overall Number of Participants Analyzed 18 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
103
(36%)
107
(38%)
5.Primary Outcome
Title PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole
Hide Description [Not Specified]
Time Frame Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 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 + ketoconazole in Period 2) and had PK data to calculate Tmax of baricitinib.
Arm/Group Title Baricitinib (Group A) Baricitinib + Ketoconazole (Group A)
Hide Arm/Group Description:
10 mg baricitinib administered orally once on Day 1 of Period 1.
10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
Overall Number of Participants Analyzed 18 17
Median (Full Range)
Unit of Measure: hours
1.00
(0.50 to 2.00)
1.00
(0.50 to 2.00)
6.Primary Outcome
Title PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole
Hide Description [Not Specified]
Time Frame Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 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 + fluconazole in Period 2) and had PK data to calculate Tmax of baricitinib.
Arm/Group Title Baricitinib (Group B) Baricitinib + Fluconazole (Group B)
Hide Arm/Group Description:
10 mg baricitinib administered orally once on Day 1 of Period 1.
10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
Overall Number of Participants Analyzed 18 17
Median (Full Range)
Unit of Measure: hours
1.00
(0.50 to 4.00)
1.00
(0.50 to 3.00)
Time Frame Baseline through study completion (up to Day 23).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib (Group A) Ketoconazole (Group A) Baricitinib + Ketoconazole (Group A) Baricitinib (Group B) Fluconazole (Group B) Baricitinib + Fluconazole (Group B)
Hide Arm/Group Description 10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3. 400 mg ketoconazole administered orally QD on Day 3 through Day 5 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 6.

10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg ketoconazole administered orally QD on Day 6 through Day 8 in Period 2.

Adverse events are reported from postdose on Day 6 up to Day 22.

10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.

400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD on Day 4 through Day 6 in Period 2.

Adverse events are reported from postdose on Day 3 through predose on Day 7.

10 mg baricitinib administered orally once on Day 7 of Period 2. 200 mg fluconazole administered orally QD on Day 7 through Day 9 in Period 2. Adverse events are reported from postdose on Day 7 up to Day 23.
All-Cause Mortality
Baricitinib (Group A) Ketoconazole (Group A) Baricitinib + Ketoconazole (Group A) Baricitinib (Group B) Fluconazole (Group B) Baricitinib + Fluconazole (Group B)
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
Baricitinib (Group A) Ketoconazole (Group A) Baricitinib + Ketoconazole (Group A) Baricitinib (Group B) Fluconazole (Group B) Baricitinib + Fluconazole (Group B)
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   0/18 (0.00%)      0/18 (0.00%)      0/17 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/17 (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 (Group A) Ketoconazole (Group A) Baricitinib + Ketoconazole (Group A) Baricitinib (Group B) Fluconazole (Group B) Baricitinib + Fluconazole (Group B)
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   4/18 (22.22%)      7/18 (38.89%)      4/17 (23.53%)      3/18 (16.67%)      4/18 (22.22%)      6/17 (35.29%)    
Eye disorders             
Vision blurred  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Anorectal discomfort  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Constipation  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Diarrhoea  1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Flatulence  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Nausea  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 0/17 (0.00%)  0
Retching  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
General disorders             
Catheter site related reaction  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Influenza like illness  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Pain  1  1/18 (5.56%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Injury, poisoning and procedural complications             
Tooth injury  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Muscle spasms  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0
Musculoskeletal pain  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/17 (5.88%)  1
Neck pain  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Nervous system disorders             
Dizziness  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0
Headache  1  3/18 (16.67%)  3 6/18 (33.33%)  7 2/17 (11.76%)  3 1/18 (5.56%)  1 0/18 (0.00%)  0 1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1
Rhinorrhoea  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  2
Skin and subcutaneous tissue disorders             
Erythema  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0
Pruritus  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  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: NCT01924299     History of Changes
Other Study ID Numbers: 14607
I4V-MC-JAGJ ( Other Identifier: Eli Lilly and Company )
First Submitted: August 14, 2013
First Posted: August 16, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017