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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014