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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06393517
• Other study ID #: C4001005
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 30, 2024
• Est. completion date: June 29, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• PF-06954522 IR (Formulation 1)
Participants to receive a single dose (Dose Level 1) of PF-06954522 Formulation 1 by mouth
• PF-06954522 MR (Formulation 2)
Participants to receive a single dose (Dose Level 1) of PF-06954522 Formulation 2 by mouth.
• PF-06954522 MR (Formulation 3)
Participants to receive a single dose (Dose Level 1) of PF-06954522 Formulation 3 by mouth

Locations

Country	Name	City	State
United States	Pfizer Clinical Research Unit	New Haven	Connecticut
United States	Pfizer Clinical Research Unit - New Haven	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Treatment-Emergent Adverse Events (AEs)		From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities		From baseline up to 72 hours after PF-06954522 dose in each period
Secondary	Number of Participants with Clinically Significant Vital Signs		From baseline up to 72 hours after PF-06954522 dose in each period
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings		From baseline up to 72 hours after PF-06954522 dose in each period
Secondary	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
Secondary	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

External Links

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