Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016

Healthy Subjects Clinical Trial

Official title:

Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739232
• Other study ID #: 3248A1-1000
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2008
• Last updated: July 31, 2009
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: July 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

This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion:

1. Men or women of nonchildbearing potential aged 18 to 50 years inclusive at screening.

2. Healthy as determined by the investigator on the basis of screening evaluations.

3. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion:

1. No presence or history of any disorder that may prevent the successful completion of the study.

2. No history of drug abuse within 1 year.

Study Design

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• HSD-016

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 and Tolerability		3 months	Yes
Secondary	Profiles of Drug Concentrations		3 months	No