A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants

Healthy 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, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF-07328948 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05654181
• Other study ID #: C4921001
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2022
• Est. completion date: May 3, 2023

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is the first clinical study with PF-07328948. The safety, tolerability, and plasma pharmacokinetics and pharmacodynamics of PF-07328948 after administration of escalating, single, oral doses will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 3, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Female participants of non-childbearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).

2. Female participants of non-childbearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

1. 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).

• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

• History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, or HCVAb. Hepatitis B vaccination is allowed.

2. 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 COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

3. 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.

4. Receipt of a COVID-19 vaccine within 7 days before screening or within 7 days before any visit in which a safety lab is planned. Vaccination with a COVID 19 vaccine that occurs greater than 7 days from either screening or any visit in which a safety lab is planned is permitted.

5. 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).

6. Screening supine BP =140 mm Hg (systolic) or =90 mm Hg (diastolic), following at least 5 minutes of supine rest.

7. Renal impairment as defined by an eGFR <75 mL/min/1.73m2 calculated using CKD EPI SCr formulas.

8. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, STT 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.

9. 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:

• AST or ALT level =1.25× 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.

10. 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).

11. 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07328948
investigational drug administered orally
• Placebo
Placebo matching active drug administered orally

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs following single ascending dose (SAD)	Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs	Day 1 up to Day 8
Primary	Number of subjects with laboratory abnormalities		Day 1 up to Day 8
Primary	Number of subjects with vital signs abnormalities	Abnormality in vital signs: Pulse rate <40 beats per minute (bpm) to >120 bpm, Diastolic blood pressure < 50 millimeter of mercury (mmHg), increase and decrease in change from baseline of >= 20mmHg, systolic blood pressure < 90 mmHg, increase and decrease in change from baseline of >= 30mmHg.	Day 1 up to Day 8
Primary	Number of Participants With Abnormal Electrocardiogram (ECG)		Day 1 up to Day 8
Primary	Change From Baseline in Electrocardiogram (ECG) Parameters	Change from baseline in PR interval, QT interval corrected using the Bazett's correction (QTcB), QT interval corrected using the Fridericia's formula (QTcF), QT interval, RR interval, QRS duration in millisecond (msec) is reported.	Day 1 up to Day 8
Secondary	Maximum concentration observed in plasma (Cmax)	Maximum concentration of PF-07328948 observed in plasma after single oral dose	Day 1 0 hour to 48-72 hours post dose
Secondary	Time to achieve Cmax (Tmax)	Time to achieve maximum concentration of PF-07328948 in plasma after single oral dose	Day 1 0 hour to 48-72 hours post dose
Secondary	Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast)	Area under the plasma concentration-time curve from time zero to the last measured concentration of PF-07328948 after single oral dose	Day 1 0 hour to 48-72 hours post dose
Secondary	Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf)	Area under the plasma concentration-time curve from time zero to extrapolated infinite time of PF-07328948 after single oral dose, if data permit	Day 1 0 hour to 48-72 hours post dose
Secondary	Terminal half-life (t1/2) of PF-07328948	The time measured for the plasma concentration of PF-07328948 to decrease by one half, if data permit	Day 1 0 hour to 48-72 hours post dose

External Links

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