A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy, Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
1 other identifier
interventional
40
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFebruary 8, 2010
February 1, 2010
5 months
August 24, 2009
February 5, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
During the course of the study and for 14 days after completing the study
Study Arms (2)
Placebo
PLACEBO COMPARATORSTX107
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Normal, healthy males 18-50 years old, inclusive.
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seaside Therapeutics, Inc.lead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Covance Clinical Research Unit
Madison, Wisconsin, 53704, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 25, 2009
Study Start
September 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
February 8, 2010
Record last verified: 2010-02