Healthy ParticipantsPhase 1NCT04628793

A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants

A Phase 1 study testing PF-07258669 in people with Healthy Participants, run by Pfizer at 1 site in United States.

Completed

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

Trial summary

This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: PF-07258669
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2021to 25 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Female participants of non-child bearing potential and male participants and who are overtly healthy as determined by medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor, as appropriate.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

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), as well as presence of lipid panel abnormalities (eg, hypercholesterolemia, hypertriglyceridemia).
Evidence of history of orthostatic hypotension or symptomatic bradycardia.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
Current findings or documented past history of blood pressure values <90 mmHg systolic or <50 mmHg diastolic.
Any lipid panel parameter (ie, total cholesterol, triglycerides, HDL, and/or LDL) ≥1.25× ULN.

Trial locations and contacts

1 site in 1 country.

United States1 site

QPS-MRA, LLC-Main Office
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07258669 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

Conditions: Healthy Participants
Being tested: PF-07258669, Placebo
Keywords: PF-07258669, first in human, melanocortin-4 receptor, MC4R, healthy participants, safety, tolerability, pharmacokinetics

What participants receive

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

PF-07258669Drug
PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined
PlaceboDrug
Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Study groups in NCT04628793
Study group	Role	What they receive
Cohort 1	Experimental	Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo. Receives: Drug: PF-07258669; Drug: Placebo
Cohort 2	Experimental	Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo. Receives: Drug: PF-07258669; Drug: Placebo
Cohort 3	Experimental	Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo. Receives: Drug: PF-07258669; Drug: Placebo

What is being measured

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Measured: From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.
Measured: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Abnormality in change from BL in vital signs included: standing diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg, standing systolic BP increase and decrease from BL of >=30mmHg, supine diastolic BP increase and decrease from BL of >=20mmHg, supine systolic BP increase and decrease from BL of >=30mmHg.
Measured: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
ECG assessments inlcuded PR, QT, QTcF intervals and QRS complex. ECG abnormalities in change from BL included: PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, QRS interval percent change from BL >=50%, QTcF change from BL >=30 and <=60msec, or change from BL >60msec.
Measured: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings
The neurological exam consisted of assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait, to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator (or designee).
Measured: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)

Secondary outcomes (5)

Maximum Observed Concentration (Cmax) of PF-07258669
Cmax is the maximum observed plasma concentration.
Measured: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669
AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Measured: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669
AUCinf is the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Measured: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Time for Cmax (Tmax) of PF-07258669
Tmax is the time for Cmax.
Measured: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Terminal Half-life (t1/2) of PF-07258669
t1/2 is the terminal half-life.
Measured: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4

Timeline

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

16 Mar 202125 Aug 2021

First posted16 Nov 2020
Study start16 Mar 2021
Primary completion25 Aug 2021
Study completion25 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04628793
Sponsor's protocol ID: C4541001
Other IDs: 2020-004280-42
Status last verified: Jul 2023
First submitted: 9 Nov 2020
Last updated: 21 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07258669 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT04628793
Acronym / sponsor ID: C4541001
Conditions: Healthy Participants
Keywords: PF-07258669, first in human, melanocortin-4 receptor, MC4R, healthy participants, safety, tolerability, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 16 Mar 2021 (actual)
Primary completion: 25 Aug 2021 (actual)
Study completion: 25 Aug 2021 (actual)
First posted: 16 Nov 2020 (actual)
Results: Posted 21 Feb 2024

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Drug: PF-07258669, Drug: PlaceboSingle dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.
Cohort 2	Experimental	Drug: PF-07258669, Drug: PlaceboSingle dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.
Cohort 3	Experimental	Drug: PF-07258669, Drug: PlaceboSingle dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Female participants of non-child bearing potential and male participants and who are overtly healthy as determined by medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor, as appropriate.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (6 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), as well as presence of lipid panel abnormalities (eg, hypercholesterolemia, hypertriglyceridemia).
Evidence of history of orthostatic hypotension or symptomatic bradycardia.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
Current findings or documented past history of blood pressure values <90 mmHg systolic or <50 mmHg diastolic.

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-07258669PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined	Drug	Cohort 1, Cohort 2, Cohort 3
PlaceboMatching placebo will be prepared as an oral solution and/or suspension given in each cohort	Drug	Cohort 1, Cohort 2, Cohort 3

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)
Time frame: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.
Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Abnormality in change from BL in vital signs included: standing diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg, standing systolic BP increase and decrease from BL of >=30mmHg, supine diastolic BP increase and decrease from BL of >=20mmHg, supine systolic BP increase and decrease from BL of >=30mmHg.
Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
ECG assessments inlcuded PR, QT, QTcF intervals and QRS complex. ECG abnormalities in change from BL included: PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, QRS interval percent change from BL >=50%, QTcF change from BL >=30 and <=60msec, or change from BL >60msec.
Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings
Time frame: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
The neurological exam consisted of assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait, to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator (or designee).

5 secondary outcomes

Maximum Observed Concentration (Cmax) of PF-07258669
Time frame: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669
Time frame: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669
Time frame: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Time for Cmax (Tmax) of PF-07258669
Time frame: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4
Terminal Half-life (t1/2) of PF-07258669
Time frame: At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4

Results and safety

Results posted to the registry on 21 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	10	8
Cohort 2	11	7
Cohort 3	8	0

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks). Count of participants. Unit: Participants

Measure	Pooled Placebo n = 18	PF-07258669 0.1mg n = 5	PF-07258669 0.3mg n = 5	PF-07258669 1mg n = 6	PF-07258669 3mg n = 6	PF-07258669 10mg n = 6	PF-07258669 30mg n = 5	PF-07258669 100mg n = 6	PF-07258669 200mg n = 6	PF-07258669 300mg n = 6
All-causality TEAEs	6	0	0	1	2	1	2	3	1	2
Treatment-related TEAEs	1	0	0	0	1	0	1	1	1	0

Population analysed: The safety analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention.

Primary outcome: Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)

Time frame: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks). Count of participants. Unit: Participants

Measure	Pooled Placebo n = 18	PF-07258669 0.1mg n = 5	PF-07258669 0.3mg n = 5	PF-07258669 1mg n = 6	PF-07258669 3mg n = 6	PF-07258669 10mg n = 6	PF-07258669 30mg n = 5	PF-07258669 100mg n = 6	PF-07258669 200mg n = 6	PF-07258669 300mg n = 6
Value	14	5	3	4	4	6	5	6	6	3

Population analysed: The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. Participants with evaluable laboratory values were analyzed.

Primary outcome: Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria

Time frame: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks). Count of participants. Unit: Participants

Measure	Pooled Placebo n = 18	PF-07258669 0.1mg n = 5	PF-07258669 0.3mg n = 5	PF-07258669 1mg n = 6	PF-07258669 3mg n = 6	PF-07258669 10mg n = 6	PF-07258669 30mg n = 5	PF-07258669 100mg n = 6	PF-07258669 200mg n = 6	PF-07258669 300mg n = 6
Standing diastolic BP increase >=20mmHg	0	0	0	0	0	0	0	0	0	0
Standing diastolic BP decrease >=20mmHg	1	0	0	0	0	0	0	1	0	0
Standing systolic BP increase >=30mmHg	0	0	0	0	0	1	0	0	0	1
Standing systolic BP decrease >=30mmHg	1	0	0	0	0	0	0	0	0	1
Supine diastolic BP increase >=20mmHg	1	0	0	0	0	0	0	0	0	0
Supine diastolic BP decrease >=20mmHg	1	0	0	1	0	0	0	1	0	0
Supine systolic BP increase >=30mmHg	1	0	0	0	0	0	0	0	0	0
Supine systolic BP decrease >=30mmHg

Primary outcome: Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria

Time frame: From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks). Count of participants. Unit: Participants

Measure	Pooled Placebo n = 18	PF-07258669 0.1mg n = 5	PF-07258669 0.3mg n = 5	PF-07258669 1mg n = 6	PF-07258669 3mg n = 6	PF-07258669 10mg n = 6	PF-07258669 30mg n = 5	PF-07258669 100mg n = 6	PF-07258669 200mg n = 6	PF-07258669 300mg n = 6
PR interval %change >=25/50% (BL >200msec and >=25% increase or BL <=200msec and >=50% increase)	0	0	0	0	0	0	0	0	0	0
QRS interval %change >=50%	0	0	0	0	0	0	0	0	0	0
QTcF change >=30 and <=60msec	0	0	0	0	0	0	0	0	0	0
QTcF change >60msec	0	0	0	0	0	0	0	0	0	0

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pooled Placebo	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18
PF-07258669 0.1mg	0 of 5 (0%)	0 of 5 (0%)	0 of 5
PF-07258669 0.3mg	0 of 5 (0%)	0 of 5 (0%)	0 of 5
PF-07258669 1mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
PF-07258669 3mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PF-07258669 10mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
PF-07258669 30mg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
PF-07258669 100mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
PF-07258669 200mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
PF-07258669 300mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07258669 in people with Healthy Participants, run by Pfizer at 1 site in United States.

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 3 inclusion and 6 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 21 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)). The study lists 5 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 NCT04628793.

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 21 Feb 2024.