Healthy Adults
Conditions
Keywords
Bioavailability, Bioequivalent
Brief summary
Study has two arms. Arm 1 has two cohorts in which each cohort, under the fasted state, will either be given a single oral dose of Form 1 in Period 1 followed by a single oral dose of Form 5 in Period 2 or a single oral dose of Form 5 in Period 1 followed by a single oral dose of Form 1 in Period 2. A single oral dose of Form 1 will be administered in Arm 2 Period 1 under the fasted state. The results from Arm 1 will inform whether a different dose of Form 5 will be administered under the fasted state or if Form 5 will be administered under the fed state in Arm 2 Period 2.
Interventions
DRUGPF-07248144
Period 1: Participants received Form 1 in a single dose of tablet fasted Period 2: Participants received Form 5 in a single dose of tablet fasted
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants of nonchildbearing potential , inclusive, at screening, who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs). * Body mass index (BMI) of 18-32 kg/m2; and a total body weight \>50 kg (110 lb)
Exclusion criteria
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention * Prior use of epigenetic modifying agents * Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s) * Additionally, current use or anticipated need for food or drugs that are known strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days or 5 half-live of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 2 days after the last dose of PF-07248144 * Proton pump inhibitors must be discontinued at least 5 days prior to the first dose of study medication and throughout treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax for PF-07248144 Form 5 film-coated tablet | 0 (pre-dose), 0.5, 1, 1.5, 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) for PF-07248144 Form 1 uncoated tablet | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose |
| AUCinf for PF-07248144 Form 5 film-coated tablet | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-07248144 Form 1 uncoated tablet | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Treatment Related AEs and SAEs | From Baseline up to Day 35 |
| Number of Participants With Laboratory Test Abnormalities | From Baseline up to Day 35 |
| Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | From Baseline up to Day 35 |
| Number of Participants With Clinically Significant Physical Examination Abnormalities | From Baseline up to Day 35 |
Countries
United States
Outcome results
None listed