A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.
Key facts
- Study ID
- NCT01719614
- Run by
- Janssen R&D Ireland
- People needed
- 20
- Starts
- 2012-10-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2014-03-06
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening
- Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
- Male participants should agree to protocol-defined use of effective contraception and women must be postmenopausal or surgically sterile
- Female participants must have a negative pregnancy test at screening
- Participants must be non-smoking for at least 3 months prior to screening
You may not qualify if…
- A positive Human immunodeficiency virus (HIV)-1 or HIV-2 test and Hepatitis A, B or C infection at screening
- Currently active clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease with any history of clinically significant skin disease
- Any history of tuberculosis, ocular herpes, or uveitis
- Have previously participated in more than one study with etravirine - TMC120 (dapivirine) and/or rilpivirine
- Participants with abnormal laboratory values at screening
Where it is running
- Study site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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