Drug Interaction Between Ritonavir And Sitaxsentan

NCT01251848

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Drug Interaction Between Ritonavir And Sitaxsentan
Official Title  ICMJE 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
Brief Summary The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE
  • Drug: Sitaxentan
    Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.
  • Drug: Ritonavir
    Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
  • Drug: Sitaxsentan
    Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days
  • Drug: Ritonavir
    Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days
Study Arms  ICMJE
  • Active Comparator: Treatment A
    Intervention: Drug: Sitaxentan
  • Active Comparator: Treatment B
    Intervention: Drug: Ritonavir
  • Experimental: Treatment C
    Interventions:
    • Drug: Sitaxsentan
    • Drug: Ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2010)
18
Estimated Study Completion Date  ICMJE February 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01251848
Other Study ID Numbers  ICMJE B1321061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP