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

This study has been terminated.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00581191
First received: December 21, 2007
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

Safety and tolerability of single oral doses in healthy subjects.


Condition Intervention Phase
Healthy
 Drug: SLV-351
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safet and tolerability [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK and PD [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: January 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.5 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 2
1 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 3
2.5 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 4
5 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 5
10 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 6
15 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 7
20 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 8
30 mg SLV-351 (fasted)
 Drug: SLV-351
SLV-351 capsules taken once
Experimental: 9
xx mg SLV-351 (fasted and fed)
 Drug: SLV-351
SLV-351 capsules taken once

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men, aged 18-50 years.
  • Women of nonchildbearing potential, aged 18-50 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581191

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Solvay Pharmaceuticals
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581191     History of Changes
Other Study ID Numbers: 3233A1-1000
Study First Received: December 21, 2007
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
SAD
Healthy

ClinicalTrials.gov processed this record on May 16, 2013