Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00981968
First received: September 21, 2009
Last updated: October 14, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Sitaxentan sodium/Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Adverse events (spontaneous and solicited) [ Time Frame: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2 ] [ Designated as safety issue: No ]
- ECGs, Vital signs, Safety laboratory test [ Time Frame: Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2 ] [ Designated as safety issue: No ]
- Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F [ Time Frame: Day 1 of Periods 1 and 2 ] [ Designated as safety issue: No ]
- Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss [ Time Frame: Days 1 and 7 of Periods 1 and 3 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- No secondary outcome [ Time Frame: No secondary outcome ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 oral dose
Other Name: Thelin
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00981968 History of Changes |
| Other Study ID Numbers: | B1321046 |
| Study First Received: | September 21, 2009 |
| Last Updated: | October 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 21, 2013