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

An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sitaxentan sodium/Placebo; Drug: Sitaxentan sodium/Placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Japanese Cohort; Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects.	Drug: Sitaxentan sodium/Placebo; 100 mg and 200 mg, tablet, single and multiple oral doses for 7 days; Other Names: Thelin; Drug: Sitaxentan sodium/Placebo; 100 mg and 200 mg, tablet, single oral dose; Other Names: Thelin
Experimental: Western Cohort; Single oral dose of sitaxentan sodium in 10 healthy subjects.	Drug: Sitaxentan sodium/Placebo; 100 mg and 200 mg, tablet, single and multiple oral doses for 7 days; Other Names: Thelin; Drug: Sitaxentan sodium/Placebo; 100 mg and 200 mg, tablet, single oral dose; Other Names: Thelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (spontaneous and solicited)	Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2
ECGs, Vital signs, Safety laboratory test	Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2
Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F	Day 1 of Periods 1 and 2
Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss	Days 1 and 7 of Periods 1 and 3

Secondary Outcome Measures

Outcome Measure	Time Frame
No secondary outcome	No secondary outcome

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 21, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Estimate): October 15, 2010
• Last Update Submitted That Met QC Criteria: October 14, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Endothelin Receptor Antagonists; Sitaxsentan
• Other Study ID Numbers: B1321046