ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00581191
Recruitment Status : Terminated
First Posted : December 27, 2007
Last Update Posted : August 4, 2009
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
Safety and tolerability of single oral doses in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: SLV-351 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safet and tolerability [ Time Frame: 35 days ]

Secondary Outcome Measures :
  1. PK and PD [ Time Frame: 35 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581191     History of Changes
Other Study ID Numbers: 3233A1-1000
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009

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