Healthy Adults
Conditions
Keywords
PF-07220060, Carbamazepine, Drug-drug interaction
Brief summary
The purpose of this study is to learn how carbamazepine changes how the body processes PF-07220060 in the body of healthy adults. This study will happen in 2 periods. The purpose of Period 1 of the study is to understand how the medicine is changed and eliminated from the body after it is taken) and safety of a single dose of PF-07220060. The purpose of Period 2 of the study is to understand how the medicine is changed and eliminated from the body after it is taken and safety of a single dose of PF-07220060 following multiple days dosing carbamazepine twice a day. Multiple blood samples will be collected in each period up to 120 hours after the PF-07220060 dose in order to measure the amount of PF-07220060 in the blood. On Day 1 in Period 1, a single oral dose of PF-07220060 will be administered with food. Period 2 will begin following the last blood sample collection in Period 1. Carbamazepine will be dosed in Period 2 at 100 mg twice a day on Days 1, 2, and 3, and then, will increase to 200 mg twice a day on Days 4, 5, 6, and 7, and will eventually increase to and be maintained at 300 mg twice a day for the rest of Period 2 from Day 8 to Day 18. On Day 14 in Period 2, a single oral dose of PF-07220060 will be administered.
Interventions
DRUGPF-07220060
Single dose PF-07220060 tablet administered with a moderate-fat standard calorie meal
DRUGCarbamazepine ER Tablet
Carbamazepine dosing titration regimen in Period 2 from Day 1 to 18
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open label
Intervention model description
This is an open-label, fixed sequence, two-period, crossover study in healthy participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Male and female participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Key
Exclusion criteria
* Participants shown to carry or be positive for human leukocyte antigen (HLA)-B\*1502 and HLA-A\*3101 (genotyping alleles/markers related with carbamazepine-associated SJS or TEN). * Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention. * Concomitant use of any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT2B7 are prohibited within 5 half-lives plus 14 days (up to 56 days) prior to first dose of PF 07220060. * Previous administration with a study intervention (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). * History of sensitivity to carbamazepine, tricyclic compounds, or any of the formulation components of carbamazepine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose. |
| Plasma PF-07220060 Area under the plasma concentration versus time curve (AUC) | Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Laboratory Abnormalities | From baseline up to 28 to 35 days after last dose of investigational drug |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | From baseline up to 28 to 35 days after last dose of investigational drug |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From baseline up to 28 to 35 days after last dose of investigational drug |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | From baseline up to 28 to 35 days after last dose of investigational drug |
Countries
United States
Outcome results
None listed