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

Sponsor
Eli Lilly and Company
Study ID
NCT01924299
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Ketoconazole — DRUG
    Administered orally
  • Fluconazole — DRUG
    Administered orally

Study Details

The main purpose of this study is to look at the effect of ketoconazole and fluconazole on how much baricitinib gets into the blood stream. The study will also look at the tolerability of baricitinib and ketoconazole when given together and the tolerability of baricitinib and fluconazole when given together. Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each treatment group will participate in 2 study periods. Participants will take baricitinib alone in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This study will last approximately 7 weeks.

Key Dates

Start date
Aug 31, 2013
Status verified
May 2017
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib + Ketoconazole
    Baricitinib - 10 milligrams (mg) administered orally once on Day 1 of Period 1 and on Day 6 of Period 2. Ketoconazole - 400 mg administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2.
  • Experimental: Baricitinib + Fluconazole
    Baricitinib - 10 mg administered orally once on Day 1 of Period 1 and on Day 7 of Period 2. Fluconazole - 400 mg 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.

Primary Outcome Measure

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 [ 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 ]

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