A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2024-01-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

4 period 4 sequence crossover design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study.

Study Groups

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Period 1 formulation 1 PF-07817883

Single oral dose of PF-07817883 tablet under fasted condition

Group Type EXPERIMENTAL

Drug: PF-07817883

Intervention Type DRUG

PF-07817883 tablet

Period 2 formulation 2 PF-07817883

Single oral dose of PF-07817883 tablet under fasted condition

Group Type EXPERIMENTAL

Drug: PF-07817883

Intervention Type DRUG

PF-07817883 tablet

Period 3 formulation 3 PF-07817883

Single oral dose of PF-07817883 tablet under fasted condition

Group Type EXPERIMENTAL

Drug: PF-07817883

Intervention Type DRUG

PF-07817883 tablet

Period 4 formulation 4 PF-07817883

Single oral dose of PF-07817883 tablet under fasted condition

Group Type EXPERIMENTAL

Drug: PF-07817883

Intervention Type DRUG

PF-07817883 tablet

Interventions

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Drug: PF-07817883

PF-07817883 tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes