Clinical trial NCT06393517: A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
timeFrame: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period
Secondary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (AEs)
timeFrame: From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1
measure: Number of Participants with Laboratory Test Abnormalities
timeFrame: From baseline up to 72 hours after PF-06954522 dose in each period
measure: Number of Participants with Summary of Post-Baseline Vital Signs Data
timeFrame: From baseline up to 72 hours after PF-06954522 dose in each period
measure: Number of Participants who met Defined Electrocardiogram (ECG) Criteria
timeFrame: From baseline up to 72 hours after PF-06954522 dose in each period
measure: 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.
timeFrame: 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period
measure: 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.
timeFrame: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: