A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults

Healthy Participants Clinical Trial

Official title:

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07293893 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05907395
• Other study ID #: C5171001
• Secondary ID: 2023-504921-37-0
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2023
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purposes of the study are: To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine. To measure the amount of PF-07293893 in blood after the medicine is taken by mouth. The study is seeking participants who: - Are females of non-childbearing potential and males 18 to 65 years of age - Are in generally healthy condition - Have not had viral infections (HIV, HBV or HCV). HIV, human immunodeficiency virus. HBV, human hepatitis B virus. HCV, human hepatitis C virus. Participants will receive either PF-07293893 or placebo (dummy pill) by chance. Participants will undergo up to 4 treatments periods in this study. Everyone will receive up to 4 doses of study medicine and up to 2 doses of placebo. In each period, participants will stay in study clinic for 5 days. There will be at least 2 days between each treatment period. Participants will be involved in this study for about 14 weeks. During their stay, participants will undergo several examinations. Participants will also have their blood collected by the study doctors for several times.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

This study is seeking participants who are:

• Females of non-childbearing potential and males 18 to 65 years of age, inclusive, at the time of signing the informed consent document (ICD) who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

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).
• History of human immunodeficiency virus infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, or hepatitis C antibody. Hepatitis B vaccination is allowed.
• Any 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.
• Screening supine blood pressure (BP) =140 mm Hg (systolic) or =90 mm Hg (diastolic) for participants <60 years; and =150/90 mm/Hg for participants =60 years old, 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
• Participants with 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: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin =1.05 × upper limit of normal (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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• PF-07293893
PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined.
• Placebo
Matching placebo will be prepared as an oral suspension given in each cohort.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit - Brussels	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)
Primary	Number of Participants With Clinical Laboratory Abnormalities		Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Primary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs		Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Primary	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings		Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Primary	Number of Participants With Clinically Significant Change From Baseline in Neurological Examination Findings		Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Primary	Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings		0 to 8 hours post-dose on Day 1 in each period
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-07293893		Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07293893		Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period
Secondary	Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07293893		Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893		Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period
Secondary	Plasma Half-Life (t1/2) of PF-07293893		Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, and 72 post-dose in each period

External Links

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