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

NCT ID: NCT00581191

Last Updated: 2009-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-03-31

Brief Summary

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Safety and tolerability of single oral doses in healthy subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

0.5 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

2

1 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

3

2.5 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

4

5 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

5

10 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

6

15 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

7

20 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

8

30 mg SLV-351 (fasted)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

9

xx mg SLV-351 (fasted and fed)

Group Type EXPERIMENTAL

SLV-351

Intervention Type DRUG

SLV-351 capsules taken once

Interventions

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SLV-351

SLV-351 capsules taken once

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men, aged 18-50 years.
* Women of nonchildbearing potential, aged 18-50 years.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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3233A1-1000

Identifier Type: -

Identifier Source: org_study_id

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