Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-05221304 administered Day 7-14

Drug: PF-05221304 administered Day 1-14

Drug: PF-06865571 administered Day 1-14

Drug: PF-06865571 administered Day 7-14

Study type

Interventional

Funder types

Industry

Identifiers

NCT03534648

DDI (Other Identifier)

2018-000694-70 (EudraCT Number)

C3711002

Details and patient eligibility

About

Drug drug interaction study between PF-05221304 and PF-06865571

Full description

A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

Healthy female subjects of nonchildbearing potential and/or male subjects.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Any condition possibly affecting drug absorption.
A positive urine drug test.
Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.