A Study of Baricitinib and Ciclosporin in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT01968057
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Ciclosporin — DRUG
    Administered orally

Study Details

The purpose of this study is to determine the effects of ciclosporin on the amount of baricitinib that is absorbed into the blood stream and the time it takes to remove baricitinib from the body. The study will also look at how well-tolerated and safe baricitinib is, when given alone and in combination with ciclosporin. Side effects will be documented. The study will last approximately 6 days from the first dose to the end of the study (not including screening or follow-up).

Key Dates

Start date
Oct 31, 2013
Status verified
May 2017
Primary completion
Dec 31, 2013
Completion
Dec 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 4 milligrams (mg) baricitinib on Day 1
  • Experimental: Baricitinib + Ciclosporin
    Single oral dose of 4 mg baricitinib co-administered with a single oral dose of 600 mg ciclosporin on Day 4

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib [ Time Frame: Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose ]

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