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Drug Interaction Study Evaluating the Effect of Rifampin on PK and Safety of PF 04965842.

NCT03637790 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-02-28

No results posted yet for this study

Summary

This is a Phase 1 open label, 2 period, single fixed sequence study designed to evaluate the effect of repeat dose oral rifampin on single dose PF 04965842 PK after a single 200 mg oral dose in healthy subjects. A total of 12 healthy male and/or female subjects will be enrolled in the study so that at least 10 subjects will complete the study.

Subject will report to the clinical research unit (CRU) at least 12 hours prior to Day 1 dosing in Period 1 and will be required to stay in the CRU for 11 days and 10 nights. Genotyping samples for CYP2C19 and CYP2C9 will be collected predose in Period 1 only. In Period 1, subjects will be administered a single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions. No food will be allowed for at least 4 hours postdose and undergo serial blood sample collection for 24 hours postdose to characterize the PK profile of PF 04965842.

In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842. Subjects will remain in a fasted state for 4 hours after dosing with PF 04965842 and undergo serial blood sample collection for 24 hours post PF 04965842 dosing to characterize the PK profile of PF 04965842. Subjects will be discharged from the CRU on Day 9 of Period 2 after all study procedures are completed. The subject will be required to return to the CRU for on site follow up visits 7 14 days, and have a follow up phone contact 28 35 days after the last dose of PF 04965842.

Conditions

  • Healthy

Interventions

DRUG

PF-04965842

single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions.In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842.

OTHER

rifampin

In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2018-12-14
Completion
2018-12-14
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03637790 on ClinicalTrials.gov