NCT00410254

Brief Summary

To evaluate the potential PK interaction of multiple oral doses of HCV-796 and a single oral dose of midazolam when coadministered to healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2007

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

December 8, 2006

Last Update Submit

December 3, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety PK

Interventions

HCV-796DRUG
midazolamDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy as determined by investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12-lead ECG.

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 796Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-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

December 8, 2006

First Posted

December 12, 2006

Study Start

June 1, 2007

Study Completion

August 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

US(2)