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
Overview
- Phase
- Phase 1
- Intervention
- PF 06835919
- Conditions
- Healthy Volunteer
- Sponsor
- Pfizer
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- AUCinf of midazolam following a single oral dose
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Sequence 1
midazolam alone followed by combination of PF 06835919 and midazolam
Intervention: PF 06835919
Sequence 1
midazolam alone followed by combination of PF 06835919 and midazolam
Intervention: Midazolam
Sequence 2
PF 06835919 in combination with midazolam followed by midazolam alone
Intervention: PF 06835919
Sequence 2
PF 06835919 in combination with midazolam followed by midazolam alone
Intervention: Midazolam
Outcomes
Primary Outcomes
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 Outcomes
- AUClast of midazolam following a single oral dose.(Baseline up to 51 days)
- Cmax of midazolam following a single oral dose.(Baseline up to 51 days)
- Incidence of Adverse Events in participants(Screening up to 79 days)