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

Wyeth

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: SLV-351

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581191

3233A1-1000

Details and patient eligibility

About

Safety and tolerability of single oral doses in healthy subjects.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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72 participants in 9 patient groups

1

Experimental group

Description:

0.5 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

2

Experimental group

Description:

1 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

3

Experimental group

Description:

2.5 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

4

Experimental group

Description:

5 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

5

Experimental group

Description:

10 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

6

Experimental group

Description:

15 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

7

Experimental group

Description:

20 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

8

Experimental group

Description:

30 mg SLV-351 (fasted)

Treatment:

Drug: SLV-351

9

Experimental group

Description:

xx mg SLV-351 (fasted and fed)

Treatment:

Drug: SLV-351