Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796

An open label, 2-period, sequential study to determine the impact of multiple doses of ketoconazole on single-dose pharmacokinetics of HCV-796

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Treatment and study plan

Ketoconazole

Drug

Primary outcomes

To evaluate the effects of multiple oral doses of ketoconazole on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects.

Secondary outcomes

To assess the safety and tolerability of HCV-796 and ketoconazole when coadministered to healthy subjects.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open Label, 2-Period, Sequential Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796

Important dates

Study start: 2006
Study completion: 2006
First posted: Oct 6, 2006
Registry last updated: Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed