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A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
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 women of non-child bearing potential between the ages of 21
and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities
identified by a detailed medical history, full physical examination, including blood
pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).

- An informed consent document signed and dated by the subject or a legally acceptable
representative.

- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

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 (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing) or clinical findings at Screening.

- A positive urine drug screen.

- Subjects with hepatic dysfunction, defined as aspartate aminotransferase (AST) and/or
alanine aminotransferase (ALT) >1.5 times the upper limit of the normal range at
Screening. A retest may be done if AST and/or ALT within 1.5- to 2- times the upper
limit of the normal range at Screening, and the average of the first and repeated test
values should be used to decide the eligibility.

NCT01244620
Pfizer
Terminated
A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

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A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses
A Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy Subjects

Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5 inhibitor).

Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: sitaxentan
    sitaxsentan 100 mg QD for 6 days
    Other Name: Thelin
  • Drug: tadalafil
    tadalafil 40 mg QD for 6 days
  • Drug: sitaxsentan
    sitaxsentan 100 mg QD for 6 days
  • Drug: sitaxsentan
    sitaxentan 100 mg QD for 6 days
  • Drug: sildenafil
    sildenafil 20 mg TID for 6 days
  • Experimental: Treatment A
    sitaxsentan 100 mg QD for 6 days (Treatment A)
    Intervention: Drug: sitaxentan
  • Experimental: Treatment B
    tadalafil 40 mg QD for 6 days
    Intervention: Drug: tadalafil
  • Experimental: Treatment C
    sitaxsentan 100 mg QD co-administered with tadalafil 40 mg QD for 6 days
    Interventions:
    • Drug: sitaxsentan
    • Drug: tadalafil
  • Experimental: Treatment D
    sitaxsentan 100 mg QD co-administered with sildenafil 20 mg TID for 6 days
    Interventions:
    • Drug: sitaxsentan
    • Drug: sildenafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects and women of non-child bearing potential between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
  • A positive urine drug screen.
  • Subjects with hepatic dysfunction, defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 times the upper limit of the normal range at Screening. A retest may be done if AST and/or ALT within 1.5- to 2- times the upper limit of the normal range at Screening, and the average of the first and repeated test values should be used to decide the eligibility.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01244620
B1321056
No
Not Provided
Not Provided
Pfizer
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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