TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers.

June 8, 2011 updated by: Tibotec Pharmaceuticals, Ireland

A Phase I, Double-blind, Double-dummy, Randomized, Placebo Controlled and Active Controlled Trial to Evaluate the Effect of TMC278 25 mg Daily at Steady-state and the Effect of Efavirenz (EFV) 600 mg Daily at Steady-state on the QT/QTc Interval, in 2 Randomized Panels of Healthy Volunteers

This is a study to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart conduction and heart rhythm) in healthy volunteers. In a separate panel of healthy volunteers, the effect of efavirenz (EFV) 600 mg daily on the QT/QTc interval will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a trial to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart conduction and heart rhythm) in healthy volunteers. In a separate panel of healthy volunteers, the effect of efavirenz (EFV) 600 mg daily on the QT/QTc interval will be evaluated. TMC278 is being investigated as a treatment for HIV-1 infection. In one panel, the effect of TMC278 at steady-state on the QT/QTc interval in healthy volunteers will be evaluated in a double-blind (neither the doctor nor the patient know if the patient is getting active drug or placebo), randomized (study drug assigned by chance), placebo controlled and positive controlled 3-way crossover design. One dose regimen of 25 mg daily of TMC278 will be tested for 11 days. In a second session, a single dose of 400 mg of moxifloxacin will be used as a positive control to assess trial sensitivity. A placebo session will be included as a reference. In a separate panel, the effect of EFV at steady-state on the QT/QTc interval in healthy volunteers will be evaluated in a double-blind, randomized, placebo controlled 2-way crossover design. One dose regimen of 600 mg daily of EFV will be tested for 11 days. Similar to the TMC278 panel, a placebo session will be included as a reference. The overall trial population will consist of 120 healthy volunteers of which at least 30% and no more than 50% are female and of which at least 20% are non-Hispanic Caucasians. Patients will be randomized in a 1:1 ratio to either the TMC278 panel or the EFV panel. The randomization between the 2 panels will be stratified by gender and ethnicity and the randomization within each panel will be stratified by gender. Each patient in the TMC278 panel will receive in 3 sessions in a random order: TMC278 25 mg daily on Day 1-11 and moxifloxacin placebo q.d. on Day 11 (Treatment A), TMC278 placebo daily on Day 1-11 and moxifloxacin placebo q.d. on Day 11 (Treatment B), and TMC278 placebo daily on Day 1-11 and moxifloxacin 400 mg q.d. on Day 11 (Treatment C). All intakes of TMC278, moxifloxacin, TMC278 placebo and moxifloxacin placebo will be under fed conditions and will take place under supervision in the unit. There will be a washout period of at least 21 days between consecutive treatments. Each patient in the EFV panel will receive in 2 sessions in a random order: EFV 600 mg daily for 11 days (Treatment D) or EFV placebo q.d. for 11 days (Treatment E). All intakes of EFV and EFV placebo will be under fasted conditions and will take place under supervision in the unit. There will be a washout period of at least 53 days between the 2 treatments. In both the TMC278 and the EFV panels, ECGs will be recorded continuously for 24 hours by Holter monitoring on Day -1 and Day 11 of all treatment sessions. In addition, for safety monitoring, 12-lead ECGs will be performed at predefined time points. Pharmacokinetic samples will be collected on Day -1, Day 9, Day 10, and Day 11, within 5 minutes after safety ECG recording or Holter extraction time point, if applicable, for the determination of TMC278, moxifloxacin or EFV plasma concentrations, as appropriate. Safety and tolerability will be monitored throughout the trial. In the TMC278 Panel, TMC278 or placebo will be given by mouth on Days 1-11 and Moxifloxican or placebo will be given by mouth on Day 11. Patients will return after each washout period for a total of 3 cycles. In the EFV Panel, EFV or placebo will be given by mouth on Days 1-11. Patients will return after the washout period for a total of 2 cycles.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must: be non-smokers (no tobacco products, nicotine or nicotine containing products of any kind for at least 1 year)
  • have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
  • be healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram, vital signs and the results of routine blood and urine tests at screening
  • have a normal 12-lead ECG at screening and on Day -1 (safety ECG) of the first treatment period.

Exclusion Criteria:

  • Patients must not: have a positive HIV-1 or -2 test at trial screening
  • be a female of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods from screening onwards until at least 30 days after last intake of trial medication
  • have a history or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
  • have Hepatitis A, B or C infection at trial screening
  • have participated in an investigational drug trial within 60 days prior to the first intake of trial medication
  • have a history of clinically relevant heart rhythm disturbances
  • have blood pressure (BP) outside of normal range (sitting systolic blood pressure <90 or >140 mmHg and/or diastolic blood pressure <40 or >90 mmHg) at screening or on Day -1 of the first treatment period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
To evaluate the effect of TMC278 25 mg daily at steady state on the QT/QTc interval in healthy volunteers.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
To evaluate steady-state PK of TMC278 25 mg daily in healthy volunteers; to evaluate the effect of EFV 600 mg daily and separately, a single dose of moxifloxican (400 mg) at steady state, on the QT/QTc interval in healthy volunteers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tibotec Pharmaceuticals, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR015088

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