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Study Evaluating HTC-867 in Healthy Young and Elderly Subjects
This study is currently recruiting participants.
Study NCT00827489   Information provided by Wyeth
First Received: January 21, 2009   Last Updated: April 24, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

January 21, 2009
April 24, 2009
January 2009
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 ]
Same as current
Complete list of historical versions of study NCT00827489 on ClinicalTrials.gov Archive Site
Pharmacokinetic and pharmacodynamic parameters. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
 
Study Evaluating HTC-867 in Healthy Young and Elderly Subjects
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects

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.

 
Phase I
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
Healthy Subjects
  • Drug: HTC-867
  • Other: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
72
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Trial Manager clintrialparticipation@wyeth.com
United States
 
 
NCT00827489
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
 
Wyeth
 
Study Director: Medical Monitor Wyeth
Wyeth
April 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.