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

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Wyeth

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: HCV-796

Study type

Interventional

Funder types

Industry

Identifiers

NCT00407173
3173A1-112

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

1
Experimental group
Description:
HCV-796 1000mg single dose
Treatment:
Drug: HCV-796

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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