A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144
- Registration Number
- NCT07198035
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to learn how the study medicine called carbamazepine changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with carbamazepine.
Carbamazepine can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected up to 8 days after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with carbamazepine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PF-07248144 with and without Carbamazepine PF-07248144 PF-07248144 administered as a single dose in Period 1 on Day 1 and in Period 2 on Day 14. Carbamazepine administered once a day for Day 1 through 3, then twice a day for Day 4 through 7, and then three times daily for Day 8 through 20 in Period 2 PF-07248144 with and without Carbamazepine Carbamazepine PF-07248144 administered as a single dose in Period 1 on Day 1 and in Period 2 on Day 14. Carbamazepine administered once a day for Day 1 through 3, then twice a day for Day 4 through 7, and then three times daily for Day 8 through 20 in Period 2
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Period 1 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose Cmax Period 2 Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) Period 1 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose AUCinf Period 2 Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast). Period 1. To be used as the primary endpoint if AUCinf cannot be reliably estimated 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose AUClast. Period 2. To be used as the primary endpoint if AUCinf cannot be reliably estimated Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose
- Secondary Outcome Measures
Name Time Method Number of Treatment-Emergent Treatment-Related AEs by Severity From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) Number of Participants With Laboratory Test Abnormalities From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) Number of Participants With Clinically Significant Physical Examination Abnormalities From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days)
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit - Brussels
🇧🇪Brussels, Other, Belgium
Pfizer Clinical Research Unit - Brussels🇧🇪Brussels, Other, Belgium