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

NCT00838461 | Completed Phase 1

• 1 other identifier: 3248A1-1002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Safety will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results.

  3 months

Secondary Outcomes (1)

• Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

HSD-016

Drug: HSD-016

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

HSD-016 DRUG

1

placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• No history of thyroid abnormalities.
• No presence or history of any disorder that may prevent the successful completion of the study.
• No history of drug abuse.
• No use of any systemic steroids for 3 months.
• No history of claustrophobia.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Chula Vista, California, 91911, United States

Location

MeSH Terms

Interventions

(R)-1,1,1-trifluoro-2-(3-((R)-4-(4-fluoro-2-(trifluoromethyl)phenyl)-2-methylpiperazin-1-ylsulfonyl)phenyl)propan-2-ol

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07

Locations

US (1)