NCT01269294

Brief Summary

The purpose of this study is to evaluate the effect of TMC435 on the results of electrocardiograms (ECGs) in healthy volunteers. An electrocardiogram is an electric recording of the heart. TMC435 is being investigated for the treatment of chronic hepatitis C virus infection.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

December 30, 2010

Last Update Submit

May 3, 2013

Conditions

Hepatitis C

Keywords

Hepatitis CTMC435-TiDP16-C117TMC435-C117TMC435HCVMoxifloxacinECGQTQTc

Outcome Measures

Primary Outcomes (2)

  • Change in QT/QTc interval for TMC435 therapeutic dose versus placebo

    24-hour measurement on Day 7 of Treatment Session A and D

  • Change in QT/QTc interval for TMC435 supratherapeutic dose versus placebo

    24-hour measurement on Day 7 of Treatment Session B and D

Secondary Outcomes (9)

  • RR interval, HR, PR interval, QRS interval and ECG morphology

    1-hour predose measurement on Day 1 of every treatment session

  • RR interval, HR, PR interval, QRS interval and ECG morphology

    24-hour measurement on Day 7 of every treatment session

  • Pharmacokinetics of 150 mg TMC435 once daily for 7 days

    Predose on Day 1 of every treatment and on Days 5 and 6 of Treatments A and B. 24 hour profile on Day 7 of Treatment A and B

  • Pharmacokinetics of 350 mg TMC435 once daily for 7 days

    Predose on Day 1 of every treatment and on Days 5 and 6 of Treatments A and B. 24 hour profile on Day 7 of Treatment A and B

  • Changes from baseline for electrocardiogram (ECG) and physical examination

    During all treatment sessions: Daily safety ECG from Day -1 to Day 9 with on Day 1 and 7 an additional safety ECG at 5h timepoint plus at screening and follow-up visits. Physical examination at screening, on Day 8 and at the follow-up visits

  • +4 more secondary outcomes

Study Arms (7)

001

EXPERIMENTAL

TMC435 2 capsules of 75 mg once daily for 7 days in Treatment A

Drug: TMC435

002

OTHER

Placebo for TMC435 2 placebo capsules once daily for 7 days in Treatment A

Drug: Placebo for TMC435

003

OTHER

Placebo for moxifloxacin 1 placebo tablet on Day 7 of Treatments A B and D

Drug: Placebo for moxifloxacin

004

EXPERIMENTAL

TMC435 2 capsules of 75 mg and 2 capsules of 100 mg once daily for 7 days in Treatment B

Drug: TMC435

005

OTHER

Placebo for TMC435 4 placebo capsules once daily for 7 days in Treatment C

Drug: Placebo for TMC435

006

OTHER

Moxifloxacin 1 tablet of 400 mg on Day 7 of Treatment C

Drug: Moxifloxacin

007

PLACEBO COMPARATOR

Placebo for TMC435 4 placebo capsules once daily for 7 days in Treatment D

Drug: Placebo for TMC435

Interventions

TMC435DRUG

2 capsules of 75 mg once daily for 7 days in Treatment A

001
Placebo for TMC435DRUG

4 placebo capsules once daily for 7 days in Treatment C

005
MoxifloxacinDRUG

1 tablet of 400 mg on Day 7 of Treatment C

006
Placebo for moxifloxacinDRUG

1 placebo tablet on Day 7 of Treatments A, B and D

003

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smokers for at least six months
  • Have a body mass index of 18.0 to 30.0 kg per square meter
  • Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening.

You may not qualify if:

  • Use of disallowed therapies, including over-the-counter products and dietary supplements
  • Any skin condition likely to interfere with ECG electrode placement or adhesion
  • History or evidence of current use of alcohol or recreational or narcotic drug use
  • Clinically relevant abnormality on ECG at screening or history of clinically relevant heart rhythm disturbances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

SimeprevirMoxifloxacin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Tibotec Pharmaceuticals Clinical Trial

    Tibotec Pharmaceutical Limited

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 30, 2010

First Posted

January 4, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 6, 2013

Record last verified: 2013-05