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

August 3, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects

Safety and tolerability of single oral doses in healthy subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safet and tolerability
Time Frame: 35 days
35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
PK and PD
Time Frame: 35 days
35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Estimate)

August 4, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3233A1-1000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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