A Study to Learn How Different Forms of the Study Medicin... | NCT06670170

Studies
A Study to Learn How Different Forms of the Study Medicine Called PF-07976016 Are Taken Up Into the Blood in Healthy Adults

NCT06670170

Sponsor

Pfizer

Status

Completed

Last Update Posted

Sep 22, 2025Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

PF-07976016 Formulation A
PF-07976016 Formulation B

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCT06670170	Registry Identifier	ClinicalTrials.gov

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2024Actual

Primary Completion Date

Dec 24, 2024Actual

Completion Date

Jan 17, 2025Actual

First Submitted Date

Oct 31, 2024

First Submission Date that Met QC Criteria

Oct 31, 2024

First Posted Date

Nov 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1	Experimental	Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.	Drug: PF-07976016 Formulation A Drug: PF-07976016 Formulation B
Sequence 2	Experimental	Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.	Drug: PF-07976016 Formulation A Drug: PF-07976016 Formulation B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-07976016 Formulation A	Drug	PF-07976016; formulation A - current/reference	Sequence 1 Sequence 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).		Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Treatment Emergent Adverse Events - TEAEs		From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
Willing to provide consent and follow study requirements
Total body weight >110lbs (50kg)

Key Exclusion Criteria:

Any condition affecting drug absorption, clinically significant laboratory values
HIV, HepB & HepC
Serious illness or hospitalization, or other condition, 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 non-prescription drugs within a specified timeframe prior to the first dose of study intervention
positive urine drug test at screening/admission
History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
Use of tobacco/nicotine containing products more than the equivalent of 5 cigarettes/day or 2 chews of tobacco/day

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Clinical Research Unit - New Haven		New Haven	Connecticut	06511	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided