Healthy ParticipantsPhase 1NCT05434091
A First-In-Human Study of the Study Medicine, Called PF-07291177, in Healthy Adult Participants
A Phase 1 study testing PF-07291177 in people with Healthy Participants, run by Pfizer.
Trial summary
The purpose of the study is to learn about the safety, tolerability (the extent to which side effects can be tolerated), and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- PF-07291177
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2022to 29 Mar 2023
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
This study is seeking participants who are:
- Female participants of non-child bearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the inform consent documents.
- Female participants of non-child bearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
This study is not seeking participants who have:
- 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).
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to coronavirus disease 2019 (COVID-19) pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- 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, with the exception of moderate/strong cytochrome P450 3A inducers or time-dependent inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
- Received a COVID-19 vaccine within 7 days before screening or any visit in which a safety lab is planned, or who are to be vaccinated with a COVID-19 vaccine within 7 days before screening or any visit in which a safety lab is planned.
- Previous administration with an investigational product (drug or vaccine) 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).
- Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- Renal impairment as defined by an estimated glomerular filtration rate (eGFR) <75 mL/min/1.73m2
- Standard 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete left bundle branch block (LBBB), signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting.
- ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Aspartate aminotransferase or Alanine aminotransferase level ≥1.25× upper limit of normal (ULN);
- Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF 07291177 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
The purpose of the study is to learn about the safety, tolerability (the extent to which side effects can be tolerated), and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth.
Read the detailed description
The purpose of the study is to learn about the safety, the extent to which side effects can be tolerated, and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth.
Each participant in this study is planned to undergo up to 4 treatment periods receiving up to 3 doses of PF 07291177 and 1 dose of placebo.
Precautionary sentinel dosing will be used in this study. Two participants (1 receiving PF 07291177 and 1 receiving placebo) within a period will be dosed initially before the remaining participants of that period are dosed.
This study is seeking :
- Female participants of non-child bearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the ICD
- Female participants of non-child bearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Conditions
- Healthy Participants
- Being tested
- PF-07291177, Placebo
- Keywords
- PF-07291177, Single ascending dose, Transthyretin, Retinol binding protein, 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-07291177Drug
PF-07291177 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 group | Role | What they receive |
|---|---|---|
| PF-07291177 and Placebo (Cohort 1) | Experimental | Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo. Receives: Drug: PF-07291177; Drug: Placebo |
| PF-07291177 and Placebo (Cohort 2) | Experimental | Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo. Receives: Drug: PF-07291177; Drug: Placebo |
| PF-07291177 and Placebo (Cohort 3) | Experimental | Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo. Receives: Drug: PF-07291177; 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 Treatment-Related Adverse Events (AEs)
Measured: Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)
Number of Participants With Clinical Laboratory Abnormalities
Measured: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Measured: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Clinically-Significant Change From Baseline in Neurological Examination Findings
Measured: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Secondary outcomes (5)
Maximum Observed Plasma Concentration (Cmax) of PF-07291177
Measured: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07291177
Measured: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07291177
Measured: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07291177
Measured: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Plasma Half-Life (t1/2) of PF-07291177
Measured: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-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.
- First posted27 Jun 2022
- Study start15 Aug 2022 (estimated)
- Primary completion29 Mar 2023 (estimated)
- Study completion29 Mar 2023 (estimated)
Why it stopped: Study stopped due to change in strategy.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434091
- Sponsor's protocol ID
- C4741003
- Other IDs
- 2022-500253-17-00
- Status last verified
- Sep 2022
- First submitted
- 22 Jun 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. 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, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF 07291177 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT05434091
- Acronym / sponsor ID
- C4741003
- Conditions
- Healthy Participants
- Keywords
- PF-07291177, Single ascending dose, Transthyretin, Retinol binding protein, Healthy participants, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to change in strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 29 Mar 2023 (estimated)
- Study completion
- 29 Mar 2023 (estimated)
- First posted
- 27 Jun 2022 (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 the study is to learn about the safety, tolerability (the extent to which side effects can be tolerated), and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth.
Detailed description
The purpose of the study is to learn about the safety, the extent to which side effects can be tolerated, and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth.
Each participant in this study is planned to undergo up to 4 treatment periods receiving up to 3 doses of PF 07291177 and 1 dose of placebo.
Precautionary sentinel dosing will be used in this study. Two participants (1 receiving PF 07291177 and 1 receiving placebo) within a period will be dosed initially before the remaining participants of that period are dosed.
This study is seeking :
- Female participants of non-child bearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the ICD
- Female participants of non-child bearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-07291177 and Placebo (Cohort 1) | Experimental | Drug: PF-07291177, Drug: PlaceboSingle dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo. |
| PF-07291177 and Placebo (Cohort 2) | Experimental | Drug: PF-07291177, Drug: PlaceboSingle dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo. |
| PF-07291177 and Placebo (Cohort 3) | Experimental | Drug: PF-07291177, Drug: PlaceboSingle dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-07291177PF-07291177 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined | Drug | PF-07291177 and Placebo (Cohort 1), PF-07291177 and Placebo (Cohort 2), PF-07291177 and Placebo (Cohort 3) |
| PlaceboMatching placebo will be prepared as an oral solution and/or suspension given in each cohort | Drug | PF-07291177 and Placebo (Cohort 1), PF-07291177 and Placebo (Cohort 2), PF-07291177 and Placebo (Cohort 3) |
Primary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Clinically-Significant Change From Baseline in Neurological Examination Findings
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of PF-07291177
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07291177
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07291177
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07291177
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Plasma Half-Life (t1/2) of PF-07291177
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- 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.
Related trials for Healthy Participants
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07291177 in people with Healthy Participants, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Treatment-Related Adverse Events (AEs) (time frame: Baseline up to 35 days after last dose of study intervention (approximately 11 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?
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 7 Sep 2022.