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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01244620
• Date of registration: 15/11/2010
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses
• Scientific title: 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
• Date of first enrolment: November 2010
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01244620
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Singapore

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.



Age minimum: 21 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: sitaxentan

Drug: sitaxsentan

Drug: tadalafil

Drug: sildenafil

Primary Outcome(s)

Area Under the Curve of the 24 Hour Dosing Interval (AUC24) [Time Frame: Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)]

Apparent Oral Clearance (CL/F) [Time Frame: Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)]

Trough Plasma Concentrations (Ctrough) [Time Frame: Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)]

Volume of Distribution at Steady State (Vss) [Time Frame: Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)]

Maximum Observed Plasma Concentration (Cmax) [Time Frame: Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)]

Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time Frame: Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)]

Secondary Outcome(s)

Plasma Decay Half-Life (t1/2) [Time Frame: Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)]

Secondary ID(s)

B1321056

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01244620