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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 IR (Formulation 1); Drug: PF-06954522 MR (Formulation 3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06393517

C4001005

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 6 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: PF-06954522 MR (Formulation 3)

Drug: PF-06954522 IR (Formulation 1)

Drug: PF-06954522 MR (Formulation 2)

Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: PF-06954522 MR (Formulation 3)

Drug: PF-06954522 IR (Formulation 1)

Drug: PF-06954522 MR (Formulation 2)

Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: PF-06954522 MR (Formulation 3)

Drug: PF-06954522 IR (Formulation 1)

Drug: PF-06954522 MR (Formulation 2)

Sequence 4

Experimental group

Description:

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.

Treatment:

Drug: PF-06954522 MR (Formulation 3)

Drug: PF-06954522 IR (Formulation 1)

Drug: PF-06954522 MR (Formulation 2)

Sequence 5

Experimental group

Description:

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.

Treatment:

Drug: PF-06954522 MR (Formulation 3)

Drug: PF-06954522 IR (Formulation 1)

Drug: PF-06954522 MR (Formulation 2)

Sequence 6

Experimental group

Description:

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.

Treatment:

Drug: PF-06954522 MR (Formulation 3)

Drug: PF-06954522 IR (Formulation 1)

Drug: PF-06954522 MR (Formulation 2)