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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00739232

Enrollment

Registered

2008-08-21

Start date

2008-09-30

Completion date

2009-02-28

Last updated

2009-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Safety and tolerability of HSD-016

Brief 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.

Interventions

DRUGHSD-016

OTHERplacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability	3 months

Secondary

Measure	Time frame
Profiles of Drug Concentrations	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026