Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251835
Recruitment Status : Withdrawn
First Posted : December 2, 2010
Last Update Posted : March 5, 2015
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Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Sitaxsentan alone Drug: Sitaxsentan Drug: Rifampin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : December 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: Sitaxsentan Drug: Sitaxsentan alone
Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)
Experimental: Sitaxsentan plus Rifampin Drug: Sitaxsentan
Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)
Drug: Rifampin
Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)

Primary Outcome Measures :
  1. Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone. [ Time Frame: 24 hours ]
  2. Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone. [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251835

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01251835     History of Changes
Other Study ID Numbers: B1321060
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: January 2011

Keywords provided by Pfizer:
Drug Interaction

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Endothelin Receptor Antagonists