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OpenTrials
Completed

NCT Number: NCT00407173

Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects

This study is an open-label, single-dose, parallel group study to evaluate the effects of age and gender on the pharmacokinetics, safety, and tolerability of HCV-796 administered orally to healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Men or nonlactating and nonpregnant women, aged 18 to 45, and >65 years.
  • Men must agree to practice barrier contraception for 12 weeks after the last test article administration.
  • Estimated (calculated) creatinine clearance must be within the age-appropriate normal range.

Exclusion:

  • History of seizures.
  • History of rhabdomyolysis.
  • History of thyroid disease.

Treatment and study plan

HCV-796

Drug

HCV-796 1000mg single dose

Primary outcomes

  1. To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages.

    Time frame: 7 days

Secondary outcomes

  1. To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages.

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • ViroPharma

Registry information

Official study title

An Open-Label, Single-Dose, Parallel Group Study to Evaluate the Effects of Age and Gender on the Pharmacokinetics, Safety, and Tolerability of HCV-796 Administered Orally to Healthy Subjects

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 4, 2006
Registry last updated
Apr 14, 2008

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.

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