Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir

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

2021-07-15

Study Completion Date

2021-10-09

Brief Summary

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This is a drug-drug interaction study to assess the effects of a single dose of PF-07321332/ritonavir after multiple dose administrations of carbamazepine. Pharmacokinetic (PK) will be evaluated for PF-07321332 and ritonavir. Carbamazepine is being utilized as a cytochrome P450 3A4 (CYP3A4) inducer.

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Detailed Description

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Conditions

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Healthy Participant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This is a Phase 1, fixed sequence, 2-period study to estimate the effect of a strong CYP3A4 inducer, carbamazepine, on the PK of PF-07321332 and ritonavir in healthy participants. 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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Period 1

PF-07321332/ritonavir orally as a single dose

Group Type EXPERIMENTAL

PF-07321332/ritonavir

Intervention Type DRUG

PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1

Period 2

Carbamazepine + PF-07321332/ritonavir orally.

Group Type EXPERIMENTAL

Carbamazepine

Intervention Type DRUG

In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.

PF 07321332/ritonavir

Intervention Type DRUG

In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.

Interventions

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PF-07321332/ritonavir

PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1

Intervention Type DRUG

Carbamazepine

In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.

Intervention Type DRUG

PF 07321332/ritonavir

In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.

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).

Exclusion Criteria

1. Positive test reverse-transcriptase polymerase chain reaction (RT-PCR) result for SARS-CoV-2 infection at the time of Screening or Day -1.
2. Subjects shown to carry or be positive for human leukocyte antigen (HLA)-B\*1502 and HLA-A\*3101
3. Participants taking monoamine oxidase inhibitors (MAOIs) should discontinue MAOI for a minimum of 14 days prior to dosing in the current study.
4. Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, vaginal ring, and postcoital contraceptive methods) and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product. Depo Provera must be discontinued at least 6 months prior to the first dose of study treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes