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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: PF 06835919; Drug: Midazolam

• Registration Number: NCT03916406
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-04-18
• Primary Completion: 2019-06-25
• Study Completion: 2019-06-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	PF 06835919	PF 06835919 in combination with midazolam followed by midazolam alone
Sequence 1	PF 06835919	midazolam alone followed by combination of PF 06835919 and midazolam
Sequence 1	Midazolam	midazolam alone followed by combination of PF 06835919 and midazolam
Sequence 2	Midazolam	PF 06835919 in combination with midazolam followed by midazolam alone

Primary Outcome Measures

Name	Time	Method
AUCinf of midazolam following a single oral dose	Baseline up to 51 days	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

Secondary Outcome Measures

Name	Time	Method
Cmax of midazolam following a single oral dose.	Baseline up to 51 days	Maximum Observed Plasma Concentration (Cmax)
Incidence of Adverse Events in participants	Screening up to 79 days
AUClast of midazolam following a single oral dose.	Baseline up to 51 days	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Trial Locations

Locations (1)

Brussels Clinical Research Unit; 🇧🇪 Brussels, Be-bru, Belgium