- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00407173
Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects
April 10, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19148
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion:
- 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.
Exclusion:
- History of seizures.
- History of rhabdomyolysis.
- History of thyroid disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
HCV-796 1000mg single dose
|
HCV-796 1000mg single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages.
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages.
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
November 29, 2006
First Submitted That Met QC Criteria
November 30, 2006
First Posted (Estimate)
December 4, 2006
Study Record Updates
Last Update Posted (Estimate)
April 14, 2008
Last Update Submitted That Met QC Criteria
April 10, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 3173A1-112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on HCV-796
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerViroPharmaCompletedHepatic Insufficiency | Hepatitis CUnited States
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimTerminated
-
Boehringer IngelheimTerminated
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted