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Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

Last updated on May 9, 2018

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Study Location
Contact
1-800-718-1021
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 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.

- Has hepatic dysfunction.

- Has history of excessive alcohol and tobacco use.

NCT01251835
Pfizer
Withdrawn
Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

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Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Pulmonary Arterial Hypertension
  • Drug: Sitaxsentan alone
    Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)
  • 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)
  • Active Comparator: Sitaxsentan
    Intervention: Drug: Sitaxsentan alone
  • Experimental: Sitaxsentan plus Rifampin
    Interventions:
    • Drug: Sitaxsentan
    • Drug: Rifampin
Not Provided


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Withdrawn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

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.
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
 
 
NCT01251835
B1321060
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

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.

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