Study Evaluating HTC-867 in Healthy Young and Elderly Subjects

September 1, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Placebo
EXPERIMENTAL: HTC-867
Drug: HTC-867

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic and pharmacodynamic parameters.
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2009

Last Update Submitted That Met QC Criteria

September 1, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3253A1-1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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