A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
Information source: Janssen R&D Ireland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Participants
Intervention: Metformin (Drug); Rilpivirine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen R&D Ireland Official(s) and/or principal investigator(s): Janssen R&D Ireland Clinical Trial, Study Director, Affiliation: Janssen R&D Ireland
Summary
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.
Clinical Details
Official title: A Phase I, Open-Label Study in Healthy Subjects to Explore the Potential for a Pharmacokinetic Interaction Between Steady-State Rilpivirine and a Single Dose Of Metformin
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum observed plasma analyte concentration (Cmax) of metforminActual sampling time to reach the maximum plasma analyte concentration (tmax) of metformin Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration after dosing (AUClast) of metformin AUC extrapolated to infinity of metformin Apparent terminal elimination rate constant of metformin Apparent terminal elimination half-life of metformin
Secondary outcome: Predose plasma analyte concentration (C0h) of rilpivirineMinimum observed plasma analyte concentration (Cmin) of rilpivirine Maximum observed plasma analyte concentration (Cmax) of rilpivirine Actual sampling time to reach the maximum plasma analyte concentration (tmax) of rilpivirine Observed plasma analyte concentration at the end of the 24-hour dosing interval (C24h) AUC from time of administration up to 24 hours after administration (AUC24h) Average steady-state plasma concentration (Css,av) Fluctuation index (FI) Number of participants with adverse events as a measure of safety and tolerability
Detailed description:
This is a phase I, open-label (all people know the identity of the intervention) and
sequential study (study medication is given in a sequence) in healthy participants, to
investigate the pharmacokinetic interaction between steady-state rilpivirine and a single
dose of metformin. The study consists of 3 phases including, the screening phase (28 days
before enrollment), treatment phase (19 days), and the follow-up phase (7 days after the
last intake of study medication). All participants will receive study medications in two
sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1)
followed by washout period (period when no treatment is received) of 4 days and then session
2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). The duration
of the study is approximately 54 days. Safety evaluations including adverse events, clinical
laboratory tests, electrocardiogram, vital signs, and physical examination (including skin
examination) will be monitored throughout the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Overland Park, Kansas, United States
Additional Information
Starting date: October 2012
Last updated: March 5, 2014
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