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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916406
• Other study ID #: C1061016
• Secondary ID: 2019-000929-42
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2019
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• PF 06835919
300 mg
• Midazolam
7.5 mg

Locations

Country	Name	City	State
Belgium	Brussels Clinical Research Unit	Brussels	Be-bru

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cmax of midazolam following a single oral dose.	Maximum Observed Plasma Concentration (Cmax)	Baseline up to 51 days
Secondary	Incidence of Adverse Events in participants		Screening up to 79 days

External Links

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