We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Study Evaluating HTC-867 in Healthy Young and Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00827489
Recruitment Status : Terminated
First Posted : January 22, 2009
Last Update Posted : September 2, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: HTC-867 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects
Study Start Date : January 2009
Primary Completion Date : April 2009
Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: HTC-867 Drug: HTC-867
Placebo Comparator: Placebo Other: Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic and pharmacodynamic parameters. [ Time Frame: 5 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  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


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827489

United States, Kansas
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00827489     History of Changes
Other Study ID Numbers: 3253A1-1000
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: September 2, 2009
Last Verified: September 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer: