Clinical trial NCT05050682: Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants
Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO INVESTIGATE THE MASS BALANCE, METABOLISM AND EXCRETION OF [14C]-PF-07304814 IN HEALTHY PARTICIPANTS USING A 14C-MICROTRACER APPROACH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: COVID-19
SARS-COV-2
Viral Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

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

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).
2. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
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. 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).
5. 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.
6. A positive urine drug test.
7. Total 14C radioactivity measured in plasma exceeding 11 mBq/mL at "Screening" .
8. Females who are breastfeeding.
9. History of tobacco or nicotine use within 3 months prior to dosing, or a positive cotinine at screening or Day -1.
10. Participants enrolled in a previous radionucleotide 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 rem per year).

13. Participants whose occupation requires exposure to radiation or monitoring of radiation exposure.

14. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Primary outcomes:
measure: Total recovery of radioactivity in urine and feces as percentage of total radioactive dose administered.
timeFrame: Predose to maximum of Day 10
measure: AUClast of intravenous radiolabeled PF-07304814 in plasma
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: Cmax of intravenous radiolabeled PF-07304814 in plasma
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: Tmax of intravenous radiolabeled PF-07304814 in plasma
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: AUCinf of intravenous radiolabeled PF-07304814 in plasma (if data permit)
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: t1/2 of intravenous radiolabeled PF-07304814 in plasma (if data permit)
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: CL of intravenous radiolabeled PF-07304814 in plasma (if data permit)
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: Vss of intravenous radiolabeled PF-07304814 in plasma (if data permit)
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: Obsereved plasma concentration at 24 hours
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
measure: Total radioactivity in plasma and pharmacokinetics of PF-00835231 and PF-07304814
timeFrame: Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Secondary outcomes:
measure: Identification and determination of relative abundance of the metabolites of PF-07304814 in plasma, urine, and feces
timeFrame: Predose to maximum of Day 10
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: