Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects

NCT00581191

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men, aged 18-50 years.

- Women of nonchildbearing potential, aged 18-50 years.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects
Official Title  ICMJE Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects
Brief Summary Safety and tolerability of single oral doses in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: SLV-351
SLV-351 capsules taken once
Study Arms  ICMJE
  • Experimental: 1
    0.5 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 2
    1 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 3
    2.5 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 4
    5 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 5
    10 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 6
    15 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 7
    20 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 8
    30 mg SLV-351 (fasted)
    Intervention: Drug: SLV-351
  • Experimental: 9
    xx mg SLV-351 (fasted and fed)
    Intervention: Drug: SLV-351
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men, aged 18-50 years.
  • Women of nonchildbearing potential, aged 18-50 years.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581191
Other Study ID Numbers  ICMJE 3233A1-1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP