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

NCT01719614 | Completed Phase 1

• 2 other identifiers: CR100909TMC278IFD1004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Healthy participants; Rilpivirine; Metformin; Pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Maximum observed plasma analyte concentration (Cmax) of metformin

  Day 1 and Day 15

• Actual sampling time to reach the maximum plasma analyte concentration (tmax) of metformin

  Day 1 and Day 15

• Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration after dosing (AUClast) of metformin

  Day 1 and Day 15

• AUC extrapolated to infinity of metformin

  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.

  Day 1 and Day 15

• Apparent terminal elimination rate constant of metformin

  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.

  Day 1 and Day 15

• Apparent terminal elimination half-life of metformin

  Day 1 and Day 15

Secondary Outcomes (9)

• Predose plasma analyte concentration (C0h) of rilpivirine

  Day 12, Day 13, Day 14, Day 15, Day 17, Day 18

• Minimum observed plasma analyte concentration (Cmin) of rilpivirine

  Day 15

• Maximum observed plasma analyte concentration (Cmax) of rilpivirine

  Day 15

• Actual sampling time to reach the maximum plasma analyte concentration (tmax) of rilpivirine

  Day 15

• Observed plasma analyte concentration at the end of the 24-hour dosing interval (C24h)

  Day 15

Study Arms (1)

Rilpivirine+Metformin

EXPERIMENTAL

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).

Drug: Metformin; Drug: Rilpivirine

Interventions

Metformin DRUG

Type=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15.

Rilpivirine+Metformin

Rilpivirine DRUG

Type=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17.

Rilpivirine+Metformin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

Metformin; Rilpivirine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

US (1)