Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2021-12-09

Brief Summary

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The purpose of this study is to estimate the effect PF-07321332/Ritonavir and Ritonavir on Midazolam (a cytochrome P450 \[CYP\]3A4 substrate) in Healthy Adult Participants.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a Phase I, crossover, 3-treatment, 6-sequence study to evaluate the effect of PF-07321332/ritonavir and ritonavir on the PK of midazolam in healthy participants. Midazolam is a substrate for CYP3A4. A total of approximately 12 healthy male and/or female participants will be enrolled into the study.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

Midazolam orally

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam administered as a single dose on Day 1

Treatment B

PF-07321332/ritonavir orally + Midazolam orally

Group Type EXPERIMENTAL

PF-07321332/ritonavir + Midazolam

Intervention Type DRUG

PF-07321332/ritonavir:

Administered orally every 12 hours for a total of 9 doses on Days 1-5

Midazolam:

Administered orally as a single dose on Day 5

Treatment C

Ritonavir orally + Midazolam orally

Group Type ACTIVE_COMPARATOR

Ritonavir + Midazolam

Intervention Type DRUG

Ritonavir:

Administered orally every 12 hours for a total of 9 doses on Day1-5.

Midazolam:

Administered orally as a single dose on Day 5

Interventions

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Midazolam

Midazolam administered as a single dose on Day 1

Intervention Type DRUG

PF-07321332/ritonavir + Midazolam

PF-07321332/ritonavir:

Administered orally every 12 hours for a total of 9 doses on Days 1-5

Midazolam:

Administered orally as a single dose on Day 5

Intervention Type DRUG

Ritonavir + Midazolam

Ritonavir:

Administered orally every 12 hours for a total of 9 doses on Day1-5.

Midazolam:

Administered orally as a single dose on Day 5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female participants of childbearing potential must have a negative (urine or serum) pregnancy test.
2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

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Exclusion Criteria

1. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
2. 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).
3. Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
4. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
5. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or hepatitis C virus (HCVAb). Hepatitis B vaccination is allowed.
6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes