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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00827489 |
The purpose of this study is to assess the safety and tolerability of ascending single oral doses of HTC-867 in healthy young and elderly subjects. This study will also evaluate the way the drug enters and leaves the blood and tissues over time and how the drug acts on and in the body in a fasted and fed state.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: HTC-867 Other: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study |
Official Title: | Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects |
Estimated Enrollment: | 72 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
HTC-867: Experimental | Drug: HTC-867 |
Placebo: Placebo Comparator | Other: Placebo |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion:
Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years or 65 or greater inclusive at screening.
WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone [FSH] ≥38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of study drug.
Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.
Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration.
Exclusion:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
United States, Florida | |
Recruiting | |
Miami, Florida, United States, 33126 | |
United States, Kansas | |
Terminated | |
Overland Park, Kansas, United States, 66211 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3253A1-1000 |
Study First Received: | January 21, 2009 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00827489 History of Changes |
Health Authority: | United States: Food and Drug Administration |
schizophrenia |
Schizophrenia Healthy |