NCT00384917

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_1 healthy

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

First QC Date

October 3, 2006

Last Update Submit

July 8, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

KetoconazoleDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ketoconazole

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

October 3, 2006

First Posted

October 6, 2006

Study Start

August 1, 2006

Study Completion

September 1, 2006

Last Updated

July 10, 2009

Record last verified: 2009-07