Drug Interaction Between Ritonavir And Sitaxsentan

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01251848
First received: December 1, 2010
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Sitaxentan
Drug: Ritonavir
Drug: Sitaxsentan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: January 2011
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A Drug: Sitaxentan
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.
Active Comparator: Treatment B Drug: Ritonavir
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
Experimental: Treatment C Drug: Sitaxsentan
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days
Drug: Ritonavir
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects and/or women of non-child bearing potential.
  • Subjects (because of teratogenic risk of sitaxsentan) 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.
  • History of significant alcohol and drug use.
  • Has hepatic dysfunction.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251848

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01251848     History of Changes
Other Study ID Numbers: B1321061
Study First Received: December 1, 2010
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Sitaxentan
ritonavir
drug interaction
pharmacokinetics

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014