Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

Pulmonary Arterial Hypertension Clinical Trial

Official title:

A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01251835
• Other study ID #: B1321060
• Status: Withdrawn
• Phase: Phase 1
• First received: December 1, 2010
• Last updated: March 4, 2015
• Start date: December 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects and/or women of non-child bearing potential.

• Subjects between the ages of 21 and 55 years, inclusive.

• Signed informed consent.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

• Has hepatic dysfunction.

• Has history of excessive alcohol and tobacco use.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Sitaxsentan alone
Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)
• Sitaxsentan
Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)
• Rifampin
Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.		24 hours	No
Primary	Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.		24 hours	No

External Links

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