Phase 1
N=12
Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir
Healthy Participant
Bottom Line
View on ClinicalTrials.gov: NCT04962230 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of PF-07321332 — 2210; 1300 nanogram per milliliter (ng/mL) — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-07321332/ritonavir (Drug); Carbamazepine (Drug); PF 07321332/ritonavir (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-07321332 |
2210; 1300 | 0.05 |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332 |
23010; 10280 | 0.05 |
| SECONDARY Cmax of Ritonavir |
359.3; 96.07 | 0.05 |
| SECONDARY AUCinf of Ritonavir |
3599; 677.6 | 0.05 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
4; 9; 0; 0; 1; 6 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332 |
3.00; 1.50 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07321332 |
22450; 10050 | 0.05 |
| SECONDARY Apparent Oral Clearance (CL/F) of PF-07321332 |
13.06; 29.17 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of PF-07321332 |
109.4; 157.2 | — |
| SECONDARY Terminal Half-Life ( t1/2) of PF-07321332 |
6.053; 3.845 | — |
| SECONDARY Tmax of Ritonavir |
3.98; 1.98 | — |
| SECONDARY AUClast of Ritonavir |
3414; 466.2 | 0.05 |
| SECONDARY CL/F of Ritonavir |
27.78; 147.6 | — |
| SECONDARY Vz/F of Ritonavir |
234.0; 697.5 | — |
| SECONDARY t1/2 of Ritonavir |
6.149; 3.345 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Female participants of childbearing potential must have a negative (urine or serum) pregnancy test.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria
- Positive test reverse-transcriptase polymerase chain reaction (RT-PCR) result for SARS-CoV-2 infection at the time of Screening or Day -1.
- Subjects shown to carry or be positive for human leukocyte antigen (HLA)-B*1502 and HLA-A*3101
- Participants taking monoamine oxidase inhibitors (MAOIs) should discontinue MAOI for a minimum of 14 days prior to dosing in the current study.
- 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.
Data sourced from ClinicalTrials.gov (NCT04962230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.