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

NCT05178654 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: C4671007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants

Keywords

Mass balance; metabolism and execration; COVID-19 (Coronavirus disease 2019); SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2)

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  Baseline (Day 0) up to 28 days after last dose of study medication

• Number of Participants With Notable Electrocardiogram (ECG) Values

  From baseline up to 11 days.

• Number of Participants With Clinically Notable Vital Signs

  From baseline up to 11 days

• 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

Study Arms (1)

[14C]PF-07321332

EXPERIMENTAL

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

Drug: [14C]PF-07321332

Interventions

[14C]PF-07321332 DRUG

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

[14C]PF-07321332

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: February 22, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share