A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants | RxWiki

A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy Participants
Intervention	Drug: Metformin Drug: Rilpivirine
Phase	Phase 1
Sponsor	Janssen R&D Ireland
Responsible Party	Janssen R&D Ireland
ClinicalTrials.gov Identifier	NCT01719614
First Received	October 30, 2012
Last Updated	March 5, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	October 30, 2012
Last Updated Date	March 5, 2014
Start Date	October 2012
Estimated Primary Completion Date	January 2013
Current Primary Outcome Measures	Maximum observed plasma analyte concentration (Cmax) of metformin [Time Frame: Day 1 and Day 15] [Designated as safety issue: No] Actual sampling time to reach the maximum plasma analyte concentration (tmax) of metformin [Time Frame: Day 1 and Day 15] [Designated as safety issue: No] Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration after dosing (AUClast) of metformin [Time Frame: Day 1 and Day 15] [Designated as safety issue: No] AUC extrapolated to infinity of metformin [Time Frame: Day 1 and Day 15] [Designated as safety issue: No]AUC extrapolated to infinity, calculated as AUClast + Clast/apparent terminal elimination rate constant, where Clast is the last measurable plasma analyte concentration; extrapolations of more than 20 percent of the total AUC are reported as approximations. Apparent terminal elimination rate constant of metformin [Time Frame: Day 1 and Day 15] [Designated as safety issue: No]Apparent terminal elimination rate constant will be estimated by linear regression using the terminal log-linear phase of the logarithmic transformed conentration versus time data. Apparent terminal elimination half-life of metformin [Time Frame: Day 1 and Day 15] [Designated as safety issue: No]
Current Secondary Outcome Measures	Predose plasma analyte concentration (C0h) of rilpivirine [Time Frame: Day 12, Day 13, Day 14, Day 15, Day 17, Day 18] [Designated as safety issue: No] Minimum observed plasma analyte concentration (Cmin) of rilpivirine [Time Frame: Day 15] [Designated as safety issue: No] Maximum observed plasma analyte concentration (Cmax) of rilpivirine [Time Frame: Day 15] [Designated as safety issue: No] Actual sampling time to reach the maximum plasma analyte concentration (tmax) of rilpivirine [Time Frame: Day 15] [Designated as safety issue: No] Observed plasma analyte concentration at the end of the 24-hour dosing interval (C24h) [Time Frame: Day 15] [Designated as safety issue: No] AUC from time of administration up to 24 hours after administration (AUC24h) [Time Frame: Day 15] [Designated as safety issue: No] Average steady-state plasma concentration (Css,av) [Time Frame: Day 15] [Designated as safety issue: No]Css,av is calculated by AUC dosing interval/dosing interval at steady-state Fluctuation index (FI) [Time Frame: Day 15] [Designated as safety issue: No]FI, percentage fluctuation is variation between maximum and minimum plasma concentration at steady-state Number of participants with adverse events as a measure of safety and tolerability [Time Frame: Up to 54 Days] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
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
Brief 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.
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.
Study Type	Interventional
Study Phase	Phase 1
Study Design	Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy Participants
Intervention	Drug: Metformin Type=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15. Other Names: MetforminDrug: Rilpivirine Type=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17.
Study Arm (s)	Experimental: Rilpivirine+Metformin 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).

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	20
Estimated Completion Date	January 2013
Estimated Primary Completion Date	January 2013
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01719614
Other Study ID Numbers	CR100909
Has Data Monitoring Committee	No
Information Provided By	Janssen R&D Ireland
Study Sponsor	Janssen R&D Ireland
Collaborators	Not Provided
Investigators	Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
Verification Date	March 2014

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