- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05434091
A First-In-Human Study of the Study Medicine, Called PF-07291177, in Healthy Adult Participants
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PF-07291177 and Placebo (Cohort 1)
Single 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 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined
Matching placebo will be prepared as an oral solution and/or suspension given in each cohort
|
Experimental: PF-07291177 and Placebo (Cohort 2)
Single 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 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined
Matching placebo will be prepared as an oral solution and/or suspension given in each cohort
|
Experimental: PF-07291177 and Placebo (Cohort 3)
Single 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 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined
Matching placebo will be prepared as an oral solution and/or suspension given in each cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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)
|
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)
|
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)
|
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)
|
Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C4741003
- 2022-500253-17-00 (Other Identifier: EU CTIS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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