We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719614
First Posted: November 1, 2012
Last Update Posted: March 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen R&D Ireland
  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 Intervention Phase
Healthy Participants Drug: Metformin Drug: Rilpivirine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:
  • Maximum observed plasma analyte concentration (Cmax) of metformin [ Time Frame: Day 1 and Day 15 ]
  • Actual sampling time to reach the maximum plasma analyte concentration (tmax) of metformin [ Time Frame: 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 [ Time Frame: Day 1 and Day 15 ]
  • AUC extrapolated to infinity of metformin [ Time Frame: Day 1 and Day 15 ]
    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 ]
    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 ]

Secondary Outcome Measures:
  • Predose plasma analyte concentration (C0h) of rilpivirine [ Time Frame: Day 12, Day 13, Day 14, Day 15, Day 17, Day 18 ]
  • Minimum observed plasma analyte concentration (Cmin) of rilpivirine [ Time Frame: Day 15 ]
  • Maximum observed plasma analyte concentration (Cmax) of rilpivirine [ Time Frame: Day 15 ]
  • Actual sampling time to reach the maximum plasma analyte concentration (tmax) of rilpivirine [ Time Frame: Day 15 ]
  • Observed plasma analyte concentration at the end of the 24-hour dosing interval (C24h) [ Time Frame: Day 15 ]
  • AUC from time of administration up to 24 hours after administration (AUC24h) [ Time Frame: Day 15 ]
  • Average steady-state plasma concentration (Css,av) [ Time Frame: Day 15 ]
    Css,av is calculated by AUC dosing interval/dosing interval at steady-state

  • Fluctuation index (FI) [ Time Frame: Day 15 ]
    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 ]

Enrollment: 20
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
Drug: 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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719614


Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  More Information

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01719614     History of Changes
Other Study ID Numbers: CR100909
TMC278IFD1004 ( Other Identifier: Janssen R&D Ireland )
First Submitted: October 30, 2012
First Posted: November 1, 2012
Last Update Posted: March 6, 2014
Last Verified: March 2014

Keywords provided by Janssen R&D Ireland:
Healthy participants
Rilpivirine
Metformin
Pharmacokinetics

Additional relevant MeSH terms:
Metformin
Rilpivirine
Hypoglycemic Agents
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents