Drug Interaction Between Ritonavir And Sitaxsentan

Back to Search
Print
Bookmark Trial

NCT01251848

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Pulmonary Arterial HypertensionPatient Reported Outcomes in Pulmonary Arterial Hypertension NCT01792622
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary Arterial HypertensionOpen Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study NCT00878943
  1. Hyderabad, Andra Pradesh
  2. Ahmedabad, Gujarat
  3. Vadodara, Gujarat
  4. Bangalore, Karnataka
  5. Noida, Uttar Pradesh
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary Arterial HypertensionAssess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension NCT00323297
  1. Los Angeles, California
  2. Detroit, Michigan
  3. Pittsburgh, Pennsylvania
  4. Houston, Texas
  5. Houston, Texas
  6. San Antonio, Texas
  7. Darlinghurst, New South Wales
  8. Chermside, Queensland
  9. Praha 2,
  10. Praha 4,
  11. Lille,
  12. Lille,
  13. Vandoeuvre Les Nancy,
  14. Berlin,
  15. Coburg,
  16. Essen,
  17. Giessen,
  18. Hannover,
  19. Homburg,
  20. Leipzig,
  21. Muenchen,
  22. Nuernberg,
  23. Wuerzburg,
  24. Haidari, Athens
  25. Haifa,
  26. Petach Tikva,
  27. Napoli,
  28. Roma,
  29. Taipei,
  30. Papworth Everard, Cambridgeshire
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary Arterial HypertensionTo Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. NCT00430716
  1. Phoenix, Arizona
  2. Augusta, Georgia
  3. Decatur, Georgia
  4. Elk Grove Village, Illinois
  5. Indianapolis, Indiana
  6. Chapel Hill, North Carolina
  7. Charlotte, North Carolina
  8. Houston, Texas
  9. Salt Lake City, Utah
  10. Richmond, Virginia
  11. Richmond, Virginia
  12. Leuven,
  13. Porto Alegre, RS
  14. Sao Paulo, SP
  15. Sofia,
  16. Sofia,
  17. Beijing,
  18. Shanghai,
  19. Haidari, Athens
  20. Hyderabad, Andhra Pradesh
  21. Ahmedabad, Gujarat
  22. Vadodara, Gujarat
  23. Bangalore, Karnataka
  24. Noida, Uttar Pradesh
  25. Pavia,
  26. Roma,
  27. Riga,
  28. Kuala Lumpur,
  29. Amsterdam,
  30. Rotterdam,
  31. Manila City,
  32. Quezon City,
  33. Krakow,
  34. Zabrze,
  35. Timisoara, Timis
  36. Iasi,
  37. Moscow,
  38. Moscow,
  39. Amphoe Mueang, Khon Kaen
  40. Bangkok,
  41. Norwich, Norfolk
  42. Newcastle Upon Tyne, Tyne and Wear
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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