Clinical trial NCT06122194: A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4 period 4 sequence crossover design
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.

Detailed description: This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.

Eligibility criteria: Inclusion Criteria:

* Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
* BMI of 16 to 32 kg/m2; and a total body weight \>45 kg
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

  1. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  2. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
* Positive test result for SARS-CoV-2 infection at admission

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07817883
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
measure: Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
measure: Number of Participants With Clinically Significant Abnormality in Vital Signs
timeFrame: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
measure: Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
timeFrame: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit - Brussels
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: