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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00981968

Enrollment

Registered

2009-09-22

Start date

2009-09-30

Completion date

2009-11-30

Last updated

2010-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGSitaxentan sodium/Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Measure	Time frame
No secondary outcome	No secondary outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026