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

• ClinicalTrials.gov Identifier: NCT03916406
• Recruitment Status: Completed
• First Posted: April 16, 2019
• Last Update Posted: July 16, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteer	Drug: PF 06835919; Drug: Midazolam	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: April 18, 2019
• Actual Primary Completion Date: June 25, 2019
• Actual Study Completion Date: June 25, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. AUCinf of midazolam following a single oral dose [ Time Frame: Baseline up to 51 days ]
   Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Belgium

Brussels Clinical Research Unit

Brussels, Be-bru, Belgium, B-1070

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03916406
• Other Study ID Numbers: C1061016; 2019-000929-42 ( EudraCT Number )
• First Posted: April 16, 2019
• Last Update Posted: July 16, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Midazolam; Adjuvants, Anesthesia; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action