NCT00581191

Brief Summary

Safety and tolerability of single oral doses in healthy subjects.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_1 healthy

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

December 21, 2007

Last Update Submit

August 3, 2009

Conditions

Healthy

Keywords

SADHealthy

Outcome Measures

Primary Outcomes (1)

  • Safet and tolerability

    35 days

Secondary Outcomes (1)

  • PK and PD

    35 days

Study Arms (9)

1

EXPERIMENTAL

0.5 mg SLV-351 (fasted)

Drug: SLV-351

2

EXPERIMENTAL

1 mg SLV-351 (fasted)

Drug: SLV-351

3

EXPERIMENTAL

2.5 mg SLV-351 (fasted)

Drug: SLV-351

4

EXPERIMENTAL

5 mg SLV-351 (fasted)

Drug: SLV-351

5

EXPERIMENTAL

10 mg SLV-351 (fasted)

Drug: SLV-351

6

EXPERIMENTAL

15 mg SLV-351 (fasted)

Drug: SLV-351

7

EXPERIMENTAL

20 mg SLV-351 (fasted)

Drug: SLV-351

8

EXPERIMENTAL

30 mg SLV-351 (fasted)

Drug: SLV-351

9

EXPERIMENTAL

xx mg SLV-351 (fasted and fed)

Drug: SLV-351

Interventions

SLV-351DRUG

SLV-351 capsules taken once

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Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 4, 2009

Record last verified: 2009-08