TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions

NCT01291563 | Completed Phase 1

• 2 other identifiers: CR017167TMC-207-TBC1003
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the QT/QTc interval in healthy volunteers.

Conditions

Healthy Volunteer

Keywords

TMC207TBC1003; TMC207; M.Tuberculosis; TBC; Moxifloxacin; ECG; QT/QTc; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• ECG evaluation as a measure of QT and QTc interval

  Measured Day -1 to Day 3

Secondary Outcomes (4)

• ECG evaluation as a measure of non-QT interval electrocardiogram parameters (RR interval, HR, PR and QRS interval)

  Measured on Day -1 until Day 3

• Plasma concentrations of TMC207 and its N-monodesmethyl metabolite (M2)

  Measured on Day -1 until Day 3

• Evaluation of the concentration-effect relationship for QT/QTc for TMC207 and M2

  Measured on Day -1 until Day 3

• Evaluation of the number of volunteers with adverse events, blood and urine tests, blood pressure and pulse tests, and ECGs as measures of safety and tolerability

  Measured on Day -1 until Day 3 and Day 8-10 and 30 to 32 days after last study drug intake as safety follow up

Study Arms (4)

001

EXPERIMENTAL

TMC207 8 tablets of TMC207 (100 mg/tablet) on Day 1

Drug: TMC207

002

PLACEBO COMPARATOR

TMC207 placebo 8 tablets of TMC207 placebo on Day 1

Drug: TMC207 placebo

003

ACTIVE COMPARATOR

Moxifloxacin 1 capsule of moxifloxacin (400 mg/capsule) on Day 2

Drug: Moxifloxacin

004

PLACEBO COMPARATOR

Moxifloxacin placebo 1 capsule of moxifloxacin placebo on Day 2

Drug: Moxifloxacin placebo

Interventions

Moxifloxacin DRUG

1 capsule of moxifloxacin (400 mg/capsule) on Day 2

003

TMC207 DRUG

8 tablets of TMC207 (100 mg/tablet) on Day 1

001

TMC207 placebo DRUG

8 tablets of TMC207 placebo on Day 1

002

Moxifloxacin placebo DRUG

1 capsule of moxifloxacin placebo on Day 2

004

Eligibility Criteria

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

You may qualify if:

• Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, and clinical laboratory tests at screening
• A Body Mass Index of 18.0 to 28.0 kg/m2, extremes included
• Women must be postmenopausal for at least two years, be surgically sterile and must have negative serum pregnancy test at screening
• Non-smoking for at least three months prior to selection.

You may not qualify if:

• Infection with Hepatitis A, B, or C virus
• Infection with the human immunodeficiency virus (HIV)
• History of, or any current medical condition which could impact the safety of the participant in the study
• Previously participated in a TMC207 trial or received an investigational drug or vaccine within 60 days before the planned start of treatment
• A positive urine drug test at screening
• Volunteers with a clinically significant ECG abnormality or any other cardiac history (unusual T wave morphology, history of additional risk for Torsade de Pointes, electrolyte abnormalities, blood pressure outside of the normal range, or history of a clinically relevant heart rhythm disturbance or with a family history of Long QT Syndrome)

Sponsors & Collaborators

• Tibotec BVBA: lead

MeSH Terms

Interventions

Moxifloxacin; bedaquiline

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 8, 2011
• Study Start: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 6, 2012

Record last verified: 2012-11