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

NCT06393517 | Completed Phase 1 FDA Drug

• 1 other identifier: C4001005
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• 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

Study Arms (6)

Sequence 1

EXPERIMENTAL

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); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

Sequence 2

EXPERIMENTAL

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); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

Sequence 3

EXPERIMENTAL

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); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

Sequence 4

EXPERIMENTAL

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); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

Sequence 5

EXPERIMENTAL

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); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

Sequence 6

EXPERIMENTAL

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); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

Interventions

PF-06954522 IR (Formulation 1) DRUG

Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

PF-06954522 MR (Formulation 2) DRUG

Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

PF-06954522 MR (Formulation 3) DRUG

Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Pfizer Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: April 30, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)