A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults

A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF IMMEDIATE-RELEASE AND MODIFIED-RELEASE FORMULATIONS OF PF-06954522 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS

The purpose of this study is to compare three finished products of PF-06954522 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-06954522 once by mouth. The participants may receive different tablets by mouth for PF-06954522.

The study will compare experiences of people receiving three different products of PF-06954522. This will help understand how much PF-06954522 is taken up into the blood for each product given.

Participants will take part into the study for about 77 days. During this time participants will have to stay onsite for 21 days. There will be one follow up (by telephone) study visit.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PF-06954522 IR (Formulation 1); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Clinical Research Unit - New Haven
    • New Haven, Connecticut, United States, 06511
      • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female participants of non-childbearing potential aged 18 years or older who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and electrocardiograms.
• Body mass index of 16-32 kg/m2; and a total body weight >50 kg (110 lbs).

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).
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or participants with suspected MTC per the investigator's judgement.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Use of any prohibited prior/concomitant medication(s).
• A positive urine drug test at screening or admission.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.	Drug: PF-06954522 IR (Formulation 1); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth; Drug: PF-06954522 MR (Formulation 2); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.; Drug: PF-06954522 MR (Formulation 3); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth
Experimental: Sequence 2; Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.	Drug: PF-06954522 IR (Formulation 1); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth; Drug: PF-06954522 MR (Formulation 2); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.; Drug: PF-06954522 MR (Formulation 3); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth
Experimental: Sequence 3; Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.	Drug: PF-06954522 IR (Formulation 1); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth; Drug: PF-06954522 MR (Formulation 2); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.; Drug: PF-06954522 MR (Formulation 3); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth
Experimental: Sequence 4; Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.	Drug: PF-06954522 IR (Formulation 1); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth; Drug: PF-06954522 MR (Formulation 2); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.; Drug: PF-06954522 MR (Formulation 3); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth
Experimental: Sequence 5; Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.	Drug: PF-06954522 IR (Formulation 1); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth; Drug: PF-06954522 MR (Formulation 2); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.; Drug: PF-06954522 MR (Formulation 3); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth
Experimental: Sequence 6; Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.	Drug: PF-06954522 IR (Formulation 1); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth; Drug: PF-06954522 MR (Formulation 2); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.; Drug: PF-06954522 MR (Formulation 3); Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.	0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.	0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to fasted state.	0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to the fasted state.	0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period
Number of Participants with Treatment-Emergent Adverse Events (AEs)	From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1
Number of Participants with Laboratory Test Abnormalities	From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants with Summary of Post-Baseline Vital Signs Data	From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants who met Defined Electrocardiogram (ECG) Criteria	From baseline up to 72 hours after PF-06954522 dose in each period

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: C4001005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No