NCT00407173

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2006

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

November 29, 2006

Last Update Submit

April 10, 2008

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    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.

    15 days

Study Arms (1)

1

EXPERIMENTAL

HCV-796 1000mg single dose

Drug: HCV-796

Interventions

HCV-796DRUG

HCV-796 1000mg single dose

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Gainesville, Florida, 32608, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Interventions

HCV 796

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 29, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

US(2)