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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

HSD-016

Group Type ACTIVE_COMPARATOR

HSD-016

Intervention Type DRUG

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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HSD-016

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes