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Study Evaluating HTC-867 in Healthy Young and Elderly Subjects
This study is currently recruiting participants.
Verified by Wyeth, April 2009
First Received: January 21, 2009   Last Updated: April 24, 2009   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00827489
  Purpose

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
Healthy Subjects
Drug: HTC-867
Other: Placebo
Phase I

U.S. FDA Resources
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

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic and pharmacodynamic parameters. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  1. 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.

  2. Healthy as determined by the investigator on the basis of screening evaluations.
  3. The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory test results that are associated with stable, chronic, and well-controlled medical conditions, so long as those deviations do not meet the stated specific criteria for exclusion

Exclusion:

  1. Presence or history of any disorder that may prevent the successful completion of the study.
  2. History of cardiac disorders (other than hypertension) including but not limited to valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or arrhythmia.
  3. History of vertigo.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827489

Contacts
Contact: Trial Manager clintrialparticipation@wyeth.com

Locations
United States, Florida
Recruiting
Miami, Florida, United States, 33126
United States, Kansas
Terminated
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

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

Keywords provided by Wyeth:
schizophrenia

Study placed in the following topic categories:
Schizophrenia
Healthy

ClinicalTrials.gov processed this record on May 06, 2009