A Study of Baricitinib and Rifampicin in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT01910311
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Rifampicin — DRUG
    Administered orally

Study Details

The purposes of this study are to look at what effect multiple doses of rifampicin have on a single dose of baricitinib and to look at the safety and tolerability of these drugs. Side effects will be documented. The study will last approximately 31 days from the first dose to the end of the study.

Key Dates

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

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib
    Single oral dose of 10 milligrams (mg) baricitinib on Day 1.
  • Experimental: Baricitinib + Rifampicin
    Oral doses of 600 mg rifampicin once daily on Days 3 to 11, with a single oral dose of 10 mg baricitinib co-administered on Day 10.

Primary Outcome Measure

PK: Maximum Concentration (Cmax) of Baricitinib [ 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 ]

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