CompletedPhase 1

A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803

United States6 participantsStarted 2022-03-31

Plain-language summary

The purpose of this study is to assess the pharmacokinetics, excretion, mass balance and metabolism of PF-07265803 (formerly known as ARRY-371797) in approximately 6 healthy adult male participants.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be male and ≥18 years of age at the time of signing the informed consent.
✓. Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) monitoring.
✓. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests , lifestyle considerations , and other study procedures.
✓. Body Mass Index of 18.0 to 32 kg/m2; and a total body weight \>50 kg (110 lb).
✓. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion criteria

✕. 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, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel disease).
✕. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
✕. Participants with a history of irregular bowel movements; e.g., less than 1 bowel movement per day, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance.
✕. 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 (eg. Contact with positive case)\] 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/potent CYP3A inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
✕. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
✕. Previous administration with an investigational drug 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).

What they're measuring

Total Recovery of Radioactivity in Urine, Expressed as Percentage of Total Radioactive Dose Administered

Timeframe: Predose, in intervals of 0-6, 6-12, 12-24, 24-48, 48-72, 72-96 hours postdose on Day 1, and each subsequent 24 hours interval up to discharge (maximum 14 days)

Total Recovery of Radioactivity in Feces, Expressed as Percentage of Total Radioactive Dose Administered

Timeframe: Predose, in intervals of each 24 hours post dose on Day 1 up to discharge (maximum 14 days)

Total Recovery of Radioactivity in Total Excretion (Urine + Feces), Expressed as Percentage of Total Radioactive Dose Administered

Timeframe: Predose, in intervals of each 24 hours post dose on Day 1 up to discharge (maximum 14 days)

Relative Abundance of PF-07265803 and Its Metabolites in Plasma, Expressed as Percentage of Radioactivity

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72, 96, 120 hours post dose on Day 1

Relative Abundance of PF-07265803 and Its Metabolites in Urine, Expressed as Percentage of Radioactivity

Timeframe: Predose, in intervals of 0-6, 6-12, 12-24, 24-48, 48-72, 72-96 hours postdose on Day 1, and each subsequent 24 hours interval up to discharge (maximum 14 days)

Relative Abundance of PF-07265803 and Its Metabolites in Feces, Expressed as Percentage of Radioactivity

Timeframe: Predose, in intervals of each 24 hours post dose on Day 1 up to discharge (maximum 14 days)

Trial details

NCT IDNCT05286281

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-26

Results submitted2023-05-25

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be male and ≥18 years of age at the time of signing the informed consent.
✓. Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) monitoring.
✓. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests , lifestyle considerations , and other study procedures.
✓. Body Mass Index of 18.0 to 32 kg/m2; and a total body weight \>50 kg (110 lb).
✓. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion criteria

✕. 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, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel disease).
✕. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
✕. Participants with a history of irregular bowel movements; e.g., less than 1 bowel movement per day, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance.
✕. 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 (eg. Contact with positive case)\] 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/potent CYP3A inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
✕. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
✕. Previous administration with an investigational drug 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).