Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00744809
Other study ID # CR015088
Secondary ID
Status Completed
Phase Phase 1
First received August 29, 2008
Last updated June 8, 2011
Start date August 2008
Est. completion date January 2009

Study information

Verified date March 2010
Source Tibotec Pharmaceuticals, Ireland
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationIreland: Irish Agriculture and Food Development Authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
TMC278; Moxifloxacin; Efavirenz


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tibotec Pharmaceuticals, Ireland

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the effect of TMC278 25 mg daily at steady state on the QT/QTc interval in healthy volunteers.
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03093506 - Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance Early Phase 1
Completed NCT00526968 - The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function Phase 1
Completed NCT03277456 - A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1 Early Phase 1
Completed NCT02922933 - A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects Phase 1
Completed NCT01464385 - Nutrition Beverage Tolerance Study Phase 2
Completed NCT01452425 - In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome Phase 1
Completed NCT01468714 - A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects Phase 1
Completed NCT02922946 - Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat Phase 1
Completed NCT00254449 - Effect of NGX-4010 on ENFD and Sensory Function Phase 1
Completed NCT01618877 - A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers Phase 1
Completed NCT01618903 - An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese Phase 1
Completed NCT00752466 - A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately Phase 1
Completed NCT00166933 - Minimal Erythema Dose of UV-B in Normal Population of Taiwan N/A
Completed NCT05519514 - Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects Phase 1
Completed NCT01776437 - Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers Phase 1
Completed NCT01437033 - Breath Test for Chemicals (Volatile Organic Compounds)
Completed NCT01445860 - Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics Phase 1
Unknown status NCT00743977 - Bioequivalence of Phenazopyridine HCl in Healthy Volunteers N/A