Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838461
• Other study ID #: 3248A1-1002
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2009
• Last updated: July 31, 2009
• Start date: March 2009
• Est. completion date: June 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 intended to provide an initial safety assessment of HSD-016 and also to evaluate how the drug is absorbed and eliminated and its effect on the body in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

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

2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day.

Exclusion criteria:

1. No history of thyroid abnormalities.

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

3. No history of drug abuse.

4. No use of any systemic steroids for 3 months.

5. No history of claustrophobia.

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

• 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 will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results.		3 months	Yes
Secondary	Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016		3 months	No