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Drug Interaction Between Ritonavir And Sitaxsentan

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NCT01251848

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT01251848
Pfizer
Withdrawn
Drug Interaction Between Ritonavir And Sitaxsentan

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Pfizer Clinical Trials Contact Center

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[email protected]

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Drug Interaction Between Ritonavir And Sitaxsentan
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
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Pulmonary Arterial Hypertension
  • 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
  • Active Comparator: Treatment A
    Intervention: Drug: Sitaxentan
  • Active Comparator: Treatment B
    Intervention: Drug: Ritonavir
  • Experimental: Treatment C
    Interventions:
    • Drug: Sitaxsentan
    • Drug: Ritonavir
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01251848
B1321061
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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