TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Simeprevir

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.