NCT00981968

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 15, 2010

Status Verified

October 1, 2010

Enrollment Period

2 months

First QC Date

September 21, 2009

Last Update Submit

October 14, 2010

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • No secondary outcome

    No secondary outcome

Study Arms (2)

Japanese Cohort

EXPERIMENTAL

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

Drug: Sitaxentan sodium/Placebo

Western Cohort

EXPERIMENTAL

Single oral dose of sitaxentan sodium in 10 healthy subjects.

Drug: Sitaxentan sodium/Placebo

Interventions

Sitaxentan sodium/PlaceboDRUG

100 mg and 200 mg, tablet, single and multiple oral doses for 7 days

Also known as: Thelin
Japanese Cohort

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

October 15, 2010

Record last verified: 2010-10

Locations

US(1)