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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00965432
Other study ID # 22006
Secondary ID
Status Completed
Phase Phase 1
First received August 24, 2009
Last updated February 5, 2010
Start date September 2009
Est. completion date February 2010

Study information

Verified date February 2010
Source Seaside Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objectives of this study are to determine the safety and tolerability of single oral doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral doses of STX107 when administered via an oral suspension


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Normal, healthy males 18-50 years old, inclusive.

- Able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
STX107
Single dose of an oral suspension

Locations

Country Name City State
United States Covance Clinical Research Unit Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Seaside Therapeutics, Inc. National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events During the course of the study and for 14 days after completing the study Yes
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