A Study to Learn How Different Products of the Study Medicine Called PF-07940367 Are Taken up Into the Blood in Healthy Adults

Healthy Clinical Trial

Official title:

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, PARALLEL DESIGN, STUDY TO EVALUATE PHARMACOKINETIC COMPARABILITY OF TWO PF-07940367 FILM-COATED TABLET FORMULATIONS ADMINISTERED AS 150 MG UNDER FASTED CONDITIONS IN HEALTHY PARTICIPANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06190561
• Other study ID #: C5351008
• Secondary ID: GBT BEFE (adult
• Status: Completed
• Phase: Phase 1
• Start date: January 15, 2024
• Est. completion date: May 7, 2024

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two finished products of PF-07940367 in terms of the uptake into the blood stream.

This study is seeking participants who are:

• Healthy male or female participants aged 18 years or older.

All participants in this study will receive PF-07940367 once by mouth. The participants may receive different tablets by mouth for PF-07940367.

The study will compare experiences of people receiving two different products of PF-07940367. This will help understand how much PF-07940367 is taken up into the blood for each product given.

Participants will take part in the study for about 112 days. During this time, participants will have to stay onsite for 5 days. There will be up to 2 additional onsite study visits and 3 remote (telephone call) study visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

• BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb).

• Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.

Exclusion Criteria:

• 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 human immunodeficiency virus (HIV) infection, hepatitis A, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antigen (HCVAb). Hepatitis B vaccination is allowed.

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

• Use of prescription or nonprescription drug, dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.

• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

• A positive urine drug test.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07940367
Participants to receive a single dose of PF-07940367 product II 150 mg by mouth
• PF-07940367
Participants to receive a single dose of PF-07940367 product I 150 mg by mouth

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to 336 hours (AUC336) of PF-07940367 dose to evaluate pharmacokinetic comparability of two PF-07940367 products		0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs)		From baseline up to 56 days after PF-07940367 dose
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities		From baseline up to 336 hours after PF-07940367 dose
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings		From baseline up to 96 hours after PF-07940367 dose
Secondary	Number of Participants With Clinically Significant Vital Signs		From baseline up to 336 hours after PF-07940367 dose
Secondary	Maximum Observed Whole Blood Concentration (Cmax) of PF-07940367 for two PF-07940367 products		0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Secondary	Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of PF-07940367 for two PF-07940367 products		0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Secondary	Time to Maximum Observed Whole Blood Concentration (Tmax) of PF-07940367 for two PF-07940367 products		0 hours (pre-dose) to 336 hours post-PF-07940367 dose

External Links

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