CClinicalTrials.gg
CompletedNCT04628793Updated Feb 21, 2024Results posted

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

A Phase 1 interventional study of PF-07258669 and Placebo in Healthy Participants, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • PF-07258669
  • first in human
  • melanocortin-4 receptor
  • MC4R
  • healthy participants
  • safety
  • tolerability
  • pharmacokinetics
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

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), 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

    Drug: PF-07258669 · Drug: Placebo

  • Experimental
    Cohort 2

    Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

    Drug: PF-07258669 · Drug: Placebo

  • Experimental
    Cohort 3

    Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

    Drug: PF-07258669 · Drug: Placebo

Interventions

  • DrugPF-07258669

    PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

  • DrugPlacebo

    Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

06

What researchers measure

Primary outcomes

  1. 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.

    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)

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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).

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

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of PF-07258669

    Cmax is the maximum observed plasma concentration.

    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

  2. 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.

    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

  3. 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.

    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

  4. Time for Cmax (Tmax) of PF-07258669

    Tmax is the time for Cmax.

    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

  5. Terminal Half-life (t1/2) of PF-07258669

    t1/2 is the terminal half-life.

    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

07

Results

Posted Feb 21, 2024

Participant flow

Participant flow — Overall Study
MilestoneCohort 1Cohort 2Cohort 3
Started10118
Period 1788
Period 2770
Period 3880
Period 4880
Completed870
Not completed248
Withdrew: Study terminated by sponsor008
Withdrew: Withdrawal by subject230
Withdrew: Lost to follow-up010

Outcome measures

PrimaryNumber 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.

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)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsPooled PlaceboPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
All-causality TEAEs6001212312
Treatment-related TEAEs1000101110
PrimaryNumber 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.

Time frame:
From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)
ParticipantsPooled PlaceboPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)14534465663
PrimaryNumber 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.

Time frame:
From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
ParticipantsPooled PlaceboPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Standing diastolic BP increase >=20mmHg0000000000
Standing diastolic BP decrease >=20mmHg1000000100
Standing systolic BP increase >=30mmHg0000010001
Standing systolic BP decrease >=30mmHg1000000001
Supine diastolic BP increase >=20mmHg1000000000
Supine diastolic BP decrease >=20mmHg1001000100
Supine systolic BP increase >=30mmHg1000000000
Supine systolic BP decrease >=30mmHg1000001011
PrimaryNumber 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.

Time frame:
From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
ParticipantsPooled PlaceboPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
PR interval %change >=25/50% (BL >200msec and >=25% increase or BL <=200msec and >=50% increase)0000000000
QRS interval %change >=50%0000000000
QTcF change >=30 and <=60msec0000000000
QTcF change >60msec0000000000
PrimaryNumber 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).

Time frame:
From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings
ParticipantsPooled PlaceboPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings0000000000
SecondaryMaximum Observed Concentration (Cmax) of PF-07258669

Cmax is the maximum observed plasma concentration.

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
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
Maximum Observed Concentration (Cmax) of PF-07258669
nanogram per milliliter (ng/mL)PF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Maximum Observed Concentration (Cmax) of PF-072586690.8439 ± 133.053 ± 3510.72 ± 4026.48 ± 3553.30 ± 24188.1 ± 3573.4 ± 451173 ± 411604 ± 64
SecondaryArea 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.

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
Reported as:
Geometric mean · nanogram*hour per milliliter (ng*hr/mL)
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669
nanogram*hour per milliliter (ng*hr/mL)PF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-072586692.421 ± 137.826 ± 3027.83 ± 2775.84 ± 29182.2 ± 16584.8 ± 112148 ± 124013 ± 215764 ± 34
SecondaryArea 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.

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
Reported as:
Geometric mean · nanogram*hour per milliliter (ng*hr/mL)
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669
nanogram*hour per milliliter (ng*hr/mL)PF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-072586692.659 ± 148.252 ± 2828.55 ± 2876.63 ± 28183.0 ± 15586.9 ± 112156 ± 124033 ± 216036 ± 32
SecondaryTime for Cmax (Tmax) of PF-07258669

Tmax is the time for Cmax.

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
Reported as:
Median · hour
Time for Cmax (Tmax) of PF-07258669
hourPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Time for Cmax (Tmax) of PF-072586691.00 (1.00 to 1.50)1.00 (0.500 to 1.00)0.750 (0.500 to 1.00)0.750 (0.500 to 1.00)1.00 (0.500 to 1.00)1.00 (1.00 to 1.00)1.00 (0.500 to 1.50)1.25 (1.00 to 2.00)1.00 (0.500 to 1.50)
SecondaryTerminal Half-life (t1/2) of PF-07258669

t1/2 is the terminal half-life.

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
Reported as:
Mean · hour
Terminal Half-life (t1/2) of PF-07258669
hourPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Terminal Half-life (t1/2) of PF-072586692.508 ± 0.924463.828 ± 0.922534.572 ± 0.933605.013 ± 0.528125.558 ± 0.789876.698 ± 1.65086.415 ± 1.59126.880 ± 1.969712.99 ± 10.045

Adverse events

Collected over 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). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pooled Placebo0/18 (0%)0/18 (0%)6/18 (33.3%)
PF-07258669 0.1mg0/5 (0%)0/5 (0%)0/5 (0%)
PF-07258669 0.3mg0/5 (0%)0/5 (0%)0/5 (0%)
PF-07258669 1mg0/6 (0%)0/6 (0%)1/6 (16.7%)
PF-07258669 3mg0/6 (0%)0/6 (0%)2/6 (33.3%)
PF-07258669 10mg0/6 (0%)0/6 (0%)1/6 (16.7%)
PF-07258669 30mg0/5 (0%)0/5 (0%)2/5 (40%)
PF-07258669 100mg0/6 (0%)0/6 (0%)3/6 (50%)
PF-07258669 200mg0/6 (0%)0/6 (0%)1/6 (16.7%)
PF-07258669 300mg0/6 (0%)0/6 (0%)2/6 (33.3%)
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPooled PlaceboPF-07258669 0.1mgPF-07258669 0.3mgPF-07258669 1mgPF-07258669 3mgPF-07258669 10mgPF-07258669 30mgPF-07258669 100mgPF-07258669 200mgPF-07258669 300mg
Upper respiratory tract infectionInfections and infestations0/180/50/50/60/60/60/52/60/60/6
Blood triglycerides increasedInvestigations1/180/50/50/60/60/61/51/61/60/6
Dermatitis contactSkin and subcutaneous tissue disorders1/180/50/50/60/61/61/50/60/60/6
Atrioventricular block first degreeCardiac disorders0/180/50/51/60/60/60/50/60/60/6
PalpitationsCardiac disorders0/180/50/50/60/60/60/50/60/61/6
SARS-CoV-2 test positiveInvestigations0/180/50/50/60/60/60/50/60/61/6
DermatitisSkin and subcutaneous tissue disorders0/180/50/50/61/60/60/50/60/60/6
Orthostatic hypotensionVascular disorders0/180/50/50/61/60/60/50/60/60/6
NauseaGastrointestinal disorders1/180/50/50/60/60/60/50/60/60/6
Noninfective gingivitisGastrointestinal disorders1/180/50/50/60/60/60/50/60/60/6

Baseline characteristics

All randomized participants who received a dose of study intervention

Age, Continuous
Age, Continuous(Years)Cohort 1Cohort 2Cohort 3Total
Median39.5 (23.0 to 54.0)42.0 (34.0 to 52.0)32.5 (20.0 to 56.0)40.0 (20.0 to 56.0)
Age, Customized
Age, Customized(Participants)Cohort 1Cohort 2Cohort 3Total
18-44 Years68519
45-60 Years43310
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1Cohort 2Cohort 3Total
Female3249
Male79420
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort 1Cohort 2Cohort 3Total
White910726
Black or African American1113
08

Study locations

1 site
  • QPS-MRA, LLC-Main Office
    South Miami, Florida 33143, United States
09

References and documents

Study documents

  • Study protocol · Nov 9, 2020
  • Statistical analysis plan · Feb 1, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04628793
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 16, 2020
Start date
Mar 16, 2021
Primary completion
Aug 25, 2021
Completion
Aug 25, 2021
Results posted
Feb 21, 2024
Last update
Feb 21, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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