Healthy ParticipantsPhase 1NCT06393517

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 study testing PF-06954522 IR (Formulation 1), PF-06954522 MR (Formulation 2) and PF-06954522 MR (Formulation 3) in people with Healthy Participants, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: PF-06954522 IR (Formulation 1), PF-06954522 MR (Formulation 2) and PF-06954522 MR (Formulation 3)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 2 sitesUnited States
Study dates: 30 Apr 2024to 1 Sep 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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 locations and contacts

2 sites in 1 country.

United States2 sites

Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
Pfizer Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

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

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
Being tested: PF-06954522 IR (Formulation 1), PF-06954522 MR (Formulation 2), PF-06954522 MR (Formulation 3)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06393517
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: PF-06954522 IR (Formulation 1); Drug: PF-06954522 MR (Formulation 2); Drug: PF-06954522 MR (Formulation 3)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
Measured: From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1
Number of Participants with Laboratory Test Abnormalities
Measured: From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants with Summary of Post-Baseline Vital Signs Data
Measured: From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants who met Defined Electrocardiogram (ECG) Criteria
Measured: 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.
Measured: 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.
Measured: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 20241 Sep 2024

First posted1 May 2024
Study start30 Apr 2024
Primary completion1 Sep 2024
Study completion1 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06393517
Sponsor's protocol ID: C4001005
Status last verified: Oct 2024
First submitted: 26 Apr 2024
Last updated: 8 Oct 2024
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06393517
Acronym / sponsor ID: C4001005
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 30 Apr 2024 (actual)
Primary completion: 1 Sep 2024 (actual)
Study completion: 1 Sep 2024 (actual)
First posted: 1 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: PF-06954522 IR (Formulation 1), Drug: PF-06954522 MR (Formulation 2), Drug: PF-06954522 MR (Formulation 3)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.
Sequence 2	Experimental	Drug: PF-06954522 IR (Formulation 1), Drug: PF-06954522 MR (Formulation 2), Drug: PF-06954522 MR (Formulation 3)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.
Sequence 3	Experimental	Drug: PF-06954522 IR (Formulation 1), Drug: PF-06954522 MR (Formulation 2), Drug: PF-06954522 MR (Formulation 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.
Sequence 4	Experimental	Drug: PF-06954522 IR (Formulation 1), Drug: PF-06954522 MR (Formulation 2), Drug: PF-06954522 MR (Formulation 3)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.
Sequence 5	Experimental	Drug: PF-06954522 IR (Formulation 1), Drug: PF-06954522 MR (Formulation 2), Drug: PF-06954522 MR (Formulation 3)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.
Sequence 6	Experimental	Drug: PF-06954522 IR (Formulation 1), Drug: PF-06954522 MR (Formulation 2), Drug: PF-06954522 MR (Formulation 3)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06954522 IR (Formulation 1)Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
PF-06954522 MR (Formulation 2)Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
PF-06954522 MR (Formulation 3)Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

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.
Time frame: 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.
Time frame: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period

6 secondary outcomes

Number of Participants with Treatment-Emergent Adverse Events (AEs)
Time frame: From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1
Number of Participants with Laboratory Test Abnormalities
Time frame: From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants with Summary of Post-Baseline Vital Signs Data
Time frame: From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants who met Defined Electrocardiogram (ECG) Criteria
Time frame: 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.
Time frame: 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.
Time frame: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06393517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.