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

NCT ID: NCT03534648

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2018-08-29

Brief Summary

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

Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Effect of PF-05221304 on PF-06865571 PK

Group Type EXPERIMENTAL

PF-06865571 administered Day 7-14

Intervention Type DRUG

PF-06865571 administered Q12hr on Days 7-14

PF-05221304 administered Day 1-14

Intervention Type DRUG

PF-05221304 administered Q12hr on Days 1-14

Effect of PF-06865571 on PF-05221304 PK

Group Type EXPERIMENTAL

PF-06865571 administered Day 1-14

Intervention Type DRUG

PF-06865571 administered Q12hr on Day 7-14

PF-05221304 administered Day 7-14

Intervention Type DRUG

PF-05221304 administered Q12hr Days 7-14

Interventions

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PF-06865571 administered Day 7-14

PF-06865571 administered Q12hr on Days 7-14

Intervention Type DRUG

PF-06865571 administered Day 1-14

PF-06865571 administered Q12hr on Day 7-14

Intervention Type DRUG

PF-05221304 administered Day 1-14

PF-05221304 administered Q12hr on Days 1-14

Intervention Type DRUG

PF-05221304 administered Day 7-14

PF-05221304 administered Q12hr Days 7-14

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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DDI

Identifier Type: OTHER

Identifier Source: secondary_id

2018-000694-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C3711002

Identifier Type: -

Identifier Source: org_study_id

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