NCT00500721

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

Enrollment Period

2 months

First QC Date

July 9, 2007

Last Update Submit

April 10, 2008

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic (PK)

    21 days

Secondary Outcomes (1)

  • Safety

    29 days

Interventions

HCV-796DRUG

HCV-796 500mg BID x 14 days

DesipramineDRUG

Period 1: Single oral dose of desipramine (50 mg) on day 1. No test article administration on days 2 to 6. Period 2: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 1 to 9. Period 3: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 10 to 14 and a single oral dose of desipramine (50 mg) on day 10.

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 ECG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Interventions

HCV 796Desipramine

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-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
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 13, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

US(1)