THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-18

Study Completion Date

2019-06-25

Brief Summary

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This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sequence 1

midazolam alone followed by combination of PF 06835919 and midazolam

Group Type EXPERIMENTAL

PF 06835919

Intervention Type DRUG

300 mg

Midazolam

Intervention Type DRUG

7.5 mg

Sequence 2

PF 06835919 in combination with midazolam followed by midazolam alone

Group Type EXPERIMENTAL

PF 06835919

Intervention Type DRUG

300 mg

Midazolam

Intervention Type DRUG

7.5 mg

Interventions

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PF 06835919

300 mg

Intervention Type DRUG

Midazolam

7.5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests.
* 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed
* Participants, who according to the product label for midazolam, would be at increased risk if dosed with midazolam (ie, including but not limited to participants with history of myasthenia gravis, chronic obstructive pulmonary disease (COPD), pulmonary insufficiency, glaucoma, concomitant central nervous system (CNS) depressants).
* History of hypersensitivity to midazolam or any other benzodiazepine

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes