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Trial record 1 of 1 for:    NCT00827489
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Study Evaluating HTC-867 in Healthy Young and Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00827489
Recruitment Status : Terminated
First Posted : January 22, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE January 21, 2009
First Posted Date  ICMJE January 22, 2009
Last Update Posted Date September 2, 2009
Study Start Date  ICMJE January 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00827489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
Pharmacokinetic and pharmacodynamic parameters. [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating HTC-867 in Healthy Young and Elderly Subjects
Official Title  ICMJE Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: HTC-867
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: HTC-867
    Intervention: Drug: HTC-867
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 21, 2009)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00827489
Other Study ID Numbers  ICMJE 3253A1-1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP