A Study of Baricitinib and Birth Control Pills in Healthy Females

Sponsor
Eli Lilly and Company
Study ID
NCT01896726
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Microgynon — DRUG
    Administered orally

Study Details

The main purpose of this study is to find out how the body absorbs and breaks down a common birth control pill called Microgynon when it is given with the study drug called baricitinib. Safety and the body's ability to tolerate baricitinib and Microgynon will also be studied. The study will last approximately 6 weeks for each participant.

Key Dates

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

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Baricitinib + Microgynon
    Microgynon \[30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel\] administered orally, once daily (QD), on Days 1 and 29. Baricitinib, 10 milligrams (mg), administered orally QD on Days 23 through 30.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol [ Time Frame: Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose ]

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