A Study of Baricitinib and Simvastatin in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT01960140
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Simvastatin — DRUG
    Administered orally

Study Details

The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 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
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Simvastatin
    Single oral dose of 40 milligrams (mg) simvastatin on Day 1.
  • Experimental: Baricitinib + Simvastatin
    Oral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid [ Time Frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose ]

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