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

NCT06122194 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C50910132023-506442-24-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of PF-07817883

  0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

• Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883

  0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Secondary Outcomes (4)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)

• Number of Participants With Laboratory Test Abnormalities

  From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

• Number of Participants With Clinically Significant Abnormality in Vital Signs

  From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

• Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)

  From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

Study Arms (4)

Period 1 formulation 1 PF-07817883

EXPERIMENTAL

Single oral dose of PF-07817883 tablet under fasted condition

Drug: Drug: PF-07817883

Period 2 formulation 2 PF-07817883

EXPERIMENTAL

Single oral dose of PF-07817883 tablet under fasted condition

Drug: Drug: PF-07817883

Period 3 formulation 3 PF-07817883

EXPERIMENTAL

Single oral dose of PF-07817883 tablet under fasted condition

Drug: Drug: PF-07817883

Period 4 formulation 4 PF-07817883

EXPERIMENTAL

Single oral dose of PF-07817883 tablet under fasted condition

Drug: Drug: PF-07817883

Interventions

Drug: PF-07817883 DRUG

PF-07817883 tablet

Period 1 formulation 1 PF-07817883; Period 2 formulation 2 PF-07817883; Period 3 formulation 3 PF-07817883; Period 4 formulation 4 PF-07817883

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 period 4 sequence crossover design

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 8, 2023
• Study Start: November 23, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)