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

A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF REPEATED DOSING OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF MIDAZOLAM IN HEALTHY PARTICIPANTS

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: PF 06835919; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Be-bru
    • Brussels, Be-bru, Belgium, B-1070
      • Brussels Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; midazolam alone followed by combination of PF 06835919 and midazolam	Drug: PF 06835919; 300 mg; Drug: Midazolam; 7.5 mg
Experimental: Sequence 2; PF 06835919 in combination with midazolam followed by midazolam alone	Drug: PF 06835919; 300 mg; Drug: Midazolam; 7.5 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Actual): June 25, 2019
• Study Completion (Actual): June 25, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: C1061016; 2019-000929-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No