Study Evaluating HTC-867 in Healthy Young and Elderly Subjects

Healthy Subjects Clinical Trial

Official title:

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00827489
• Other study ID #: 3253A1-1000
• Status: Terminated
• Phase: Phase 1
• First received: January 21, 2009
• Last updated: September 1, 2009
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: September 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• HTC-867

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities.		5 months	Yes
Secondary	Pharmacokinetic and pharmacodynamic parameters.		5 months	No