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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050682
• Other study ID #: C4611003
• Status: Completed
• Phase: Phase 1
• Start date: October 7, 2021
• Est. completion date: December 10, 2021

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07304814
PF-07304814 is an anti-viral, formulated for intravenous delivery

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total recovery of radioactivity in urine and feces as percentage of total radioactive dose administered.	To characterize the extent of excretion of total radioactivity in urine and feces following administration of 24 hour single intravenous infusion of radiolabeled PF-07304814	Predose to maximum of Day 10
Primary	AUClast of intravenous radiolabeled PF-07304814 in plasma	Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radiolabeled PF-07304814 following intravenous infusion of radiolabeled PF-07304814 .	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	Cmax of intravenous radiolabeled PF-07304814 in plasma	Maximum plasma concentration of radiolabeled PF-07304814 following intravenous infusion of radiolabeled PF-07304814 .	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	Tmax of intravenous radiolabeled PF-07304814 in plasma	Time to Cmax following intravenous infusion of radiolabeled PF-07304814	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	AUCinf of intravenous radiolabeled PF-07304814 in plasma (if data permit)	Area under the plasma concentration-time profile from time zero extrapolated to infinite time following intravenous infusion of radiolabeled PF-07304814 .	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	t1/2 of intravenous radiolabeled PF-07304814 in plasma (if data permit)	Terminal elimination half-life following intravenous infusion of radiolabeled PF-07304814	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	CL of intravenous radiolabeled PF-07304814 in plasma (if data permit)	Systemic clearance following intravenous infusion of radiolabeled PF-07304814.	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	Vss of intravenous radiolabeled PF-07304814 in plasma (if data permit)	Steady-state volume of distribution following intravenous infusion of radiolabeled PF-07304814.	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	Obsereved plasma concentration at 24 hours	Plasma concentration at 24hour following intravenous infusion of radiolabeled PF-07304814 .	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Primary	Total radioactivity in plasma and pharmacokinetics of PF-00835231 and PF-07304814	To characterize total radioactivity (PF-07304814 and PF-00835231) in plasma following administration of 24 hour single intravenous infusion of radiolabeled PF-07304814	Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose
Secondary	Identification and determination of relative abundance of the metabolites of PF-07304814 in plasma, urine, and feces	To identify metabolites of PF 07304814 in plasma, urine and feces, if possible	Predose to maximum of Day 10

External Links

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