Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Sitaxentan sodium/Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00981968

B1321046

Details and patient eligibility

About

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.

Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight >45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.

Exclusion criteria

Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Japanese Cohort

Experimental group

Description:

Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects.

Treatment:

Drug: Sitaxentan sodium/Placebo

Drug: Sitaxentan sodium/Placebo

Western Cohort

Experimental group

Description:

Single oral dose of sitaxentan sodium in 10 healthy subjects.

Treatment:

Drug: Sitaxentan sodium/Placebo

Drug: Sitaxentan sodium/Placebo