NCT00384280

Brief Summary

An open label, 2-period, sequential study to determine the impact of multiple doses of rifampin 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 Sep 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

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
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

August 12, 2009

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

October 3, 2006

Last Update Submit

August 10, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effects of multiple oral doses of rifampin 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 rifampin when coadministered to healthy subjects.

Interventions

RifampinDRUG

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

Rifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic 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

September 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

August 12, 2009

Record last verified: 2009-08