Human Volunteers Clinical Trial
Official title:
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
| 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 |
NCT01468714 -
A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01452425 -
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
|
Phase 1 | |
| Completed |
NCT01464385 -
Nutrition Beverage Tolerance Study
|
Phase 2 | |
| 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 |
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 |
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 |
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 |