CompletedPhase 1

Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants

United States5 participantsStarted 2021-10-07

Plain-language summary

This open-label, single dose study in approximately 5 healthy male and female (of non childbearing potential only) participants has been designed to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of PF 07304814 administered at a dose of 500 mg \[14C\] PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 as a constant-rate, continuous IV infusion over 24 hours

Who can participate

Age range18 Years – 55 Years

SexALL

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

✓. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
✓. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
✓. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
✓. BMI of 18 to 32 kg/m2; and a total body weight \>50 kg (110 lb).

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).
✕. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
✕. 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.
✕. 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).
✕. Participants who have received a COVID-19 vaccine within the past 2 weeks; and/or participants who are scheduled to receive a second COVID-19 vaccination dose during the in-clinical period of this study.

What they're measuring

The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered

Timeframe: from pre-dose to 216h post the start of infusion

The Mean (SD) Amount of [14C] Recovered in Feces, as a Percent of the Total [14C] Dose Administered

Timeframe: from pre-dose to 216h post the start of infusion

The Mean (SD) Percentage of [14C] Relative to the Administered Dose in Excreta (Urine + Feces)

Timeframe: from pre-dose to 216h post the start of infusion

Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma PF-07304814 and Plasma PF-00835231

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma Total [14C]

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Area Under the Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Plasma PF-00835231

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Trial details

NCT IDNCT05050682

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-10

Results submitted2022-12-05

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

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

✓. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
✓. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
✓. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
✓. BMI of 18 to 32 kg/m2; and a total body weight \>50 kg (110 lb).

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).
✕. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
✕. 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.
✕. 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).
✕. Participants who have received a COVID-19 vaccine within the past 2 weeks; and/or participants who are scheduled to receive a second COVID-19 vaccination dose during the in-clinical period of this study.

What they're measuring

The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered

Timeframe: from pre-dose to 216h post the start of infusion

The Mean (SD) Amount of [14C] Recovered in Feces, as a Percent of the Total [14C] Dose Administered

Timeframe: from pre-dose to 216h post the start of infusion

The Mean (SD) Percentage of [14C] Relative to the Administered Dose in Excreta (Urine + Feces)

Timeframe: from pre-dose to 216h post the start of infusion

Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma PF-07304814 and Plasma PF-00835231

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma Total [14C]

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Area Under the Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Plasma PF-00835231

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion