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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: SLV-351

• Registration Number: NCT00581191
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Safety and tolerability of single oral doses in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-27
• Study Start: 2008-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SLV-351	0.5 mg SLV-351 (fasted)
2	SLV-351	1 mg SLV-351 (fasted)
3	SLV-351	2.5 mg SLV-351 (fasted)
4	SLV-351	5 mg SLV-351 (fasted)
6	SLV-351	15 mg SLV-351 (fasted)
8	SLV-351	30 mg SLV-351 (fasted)
9	SLV-351	xx mg SLV-351 (fasted and fed)
5	SLV-351	10 mg SLV-351 (fasted)
7	SLV-351	20 mg SLV-351 (fasted)

Primary Outcome Measures

Name	Time	Method
Safet and tolerability	35 days

Secondary Outcome Measures

Name	Time	Method
PK and PD	35 days