Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.

Healthy Participants Clinical Trial

Official title:

A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO INVESTIGATE THE MASS BALANCE, METABOLISM AND EXCRETION OF [14C]PF-07321332 IN HEALTHY MALE PARTICIPANTS

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05178654
• Other study ID #: C4671007
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 22, 2022
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of radiolabeled [14C]PF-07321332 in healthy male participants following oral administration with ritonavir.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.

• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

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

Exclusion Criteria:

• Positive test result for SARS-CoV-2 infection at the time of Screening or Day -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).

• Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).

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

• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed.

• 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.

• Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.

• A positive urine drug test.

• Participants enrolled in a previous radio-nucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry (ie, occupational exposure of 5 rems per year).

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• [14C]PF-07321332
Single oral dose of 300 mg [14C]PF-07321332 containing approximately 100 µCi [14C]PF-07321332 coadministered with 100 mg ritonavir.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative amount of radioactivity Recovered in Urine (Ae)	Ae is the cumulative amount of radioactivity recovered in urine. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.	0 to 240 hours
Primary	Cumulative amount of radioactivity Recovered in Feces (Ae)	Fe is the cumulative amount of radioactivity recovered in feces. Cumulative amount was calculated as sum of feces drug concentration in sample volume for each collection interval. Sample volume = (feces weight in gram [g]).	0 to 240 hours
Primary	Metabolic Profiling in blood	Metabolic profiling/identification and determination of relative abundance of [14C]PF-07321332 and the metabolites of [14C]PF-07321332 in plasma if possible.	0 to 24 hours
Primary	Metabolic Profiling in Urine	Metabolic profiling/identification and determination of relative abundance of [14C]PF-07321332 and the metabolites of [14C]PF-07321332 in urine if possible.	0 to 240 hours
Primary	Metabolic Profiling in Feces	Metabolic profiling/identification and determination of relative abundance of [14C]PF-07321332 and the metabolites of [14C]PF-07321332 in feces if possible.	0 to 240 hours
Secondary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline (Day 0) up to 28 days after last dose of study medication
Secondary	Number of Participants With Notable Electrocardiogram (ECG) Values		From baseline up to 11 days.
Secondary	Number of Participants With Clinically Notable Vital Signs		From baseline up to 11 days
Secondary	Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade		From baseline up to 11 days

External Links

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