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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participant

Treatments: Drug: PF 07321332/ritonavir; Drug: PF-07321332/ritonavir; Drug: Carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04962230

C4671014

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Period 1

Experimental group

Description:

PF-07321332/ritonavir orally as a single dose

Treatment:

Drug: PF-07321332/ritonavir

Period 2

Experimental group

Description:

Carbamazepine + PF-07321332/ritonavir orally.

Treatment:

Drug: Carbamazepine

Drug: PF 07321332/ritonavir