A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body.

Healthy Participants Clinical Trial

Official title:

A Phase 1, Open-Label, Fixed-Sequence, 2-Period Study in Healthy Adult Male Participants to Assess the Mass Balance, Absolute Bioavailability, Fraction Absorbed, and Pharmacokinetics of [14C]PF-06821497 Using a 14C-Microtracer Approach

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392230
• Other study ID #: C2321007
• Secondary ID: 2023-508371-36-0
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 24, 2024
• Est. completion date: August 9, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn how a certain amount of [14C] PF-06821497 is taken up into the bloodstream and removed from the body.

The study is seeking participants who are:

• Males aged 18 years or older.

• Are confirmed to be healthy after performing some medical and physical tests.

• Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared.

The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-06821497 by mouth. Part two will begin at least 14 days after the dose in part one. In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of [14C]PF-06821497 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.

To understand how the medicine is processed in the body, samples of blood, urine, and feces will be collected after each dose is given. This will help understand:

• How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV

• How the body removes it from the bloodstream.

Participants will take part in the study for about 11 weeks, including the initial evaluation and follow-up periods.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: August 9, 2024
• Est. primary completion date: August 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Key eligibility criteria for this study include, but are not limited to the following:

Inclusion Criteria:

• Male participants aged 18 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

• Body mass index (BMI) of 16-32 kg/m2; and a total body weight of >50kg (110lb)

• Participants who are willing to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, prior bariatric surgery, ileal resection, inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease).

• Chronic liver diseases including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, or other chronic liver disease.

• Previous administration with an investigational product (drug or vaccine) 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). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

• Total [14C] radioactivity measured in plasma at screening exceeding 11 mBq/mL

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Oral [14C] PF-06821497
A single oral dose of [14C] PF-06821497 will be administered as an extemporaneous suspension in Period 1
• Oral PF-06821497
A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2
• IV [14C] PF-06821497
A single IV infusion of [14C] PF-06821497 will be administered at the Tmax after administration of the unlabeled oral dose of PF-06821497 in Period 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total recovery of radioactivity in urine, feces, and total excreta (urine + feces) as percentage of total radioactive dose administered	To characterize the extent of excretion of total radioactivity in urine and feces following administration of a single oral dose of [14C]PF-06821497	Period 1 pre-dose to maximum Day 14
Primary	Metabolic profiling/identification and determination of relative abundance of [14C]PF-06821497 and the metabolites of [14C]PF-06821497 in plasma, urine, and feces	Amount of metabolites of [14C]PF-06821497 in plasma, urine, and feces	Period 1 pre-dose to maximum Day 14
Secondary	Absolute oral bioavailability (F) of [14C]PF-06821497	To determine the absolute oral bioavailability (F) of PF-06821497 by comparing AUCinf following administration of a single oral dose of PF-06821497 to a single IV microtracer of [14C]PF 06821497	Period 2 pre-dose to maximum Day 5
Secondary	Fraction of [14C]PF 06821497 dose absorbed (Fa)	To determine the fraction of the dose absorbed (Fa) following administration of a single oral dose of [14C]PF 06821497 from total urinary radioactivity of [14C]PF 06821497 in Period 1 and IV microtracer microdose administration of [14C]PF 06821497 in Period 2	Period 1 pre-dose to maximum Day 14; Period 2 pre-IV dose to maximum Day 5
Secondary	AUClast of total radioactivity and PF-06821497 in plasma	To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.	Period 1 pre-dose to maximum Day 14
Secondary	Cmax of total radioactivity and PF-06821497 in plasma	To quantify plasma peak concentration (Cmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.	Period 1 pre-dose to maximum Day 14
Secondary	Tmax of total radioactivity and PF-06821497 in plasma	To quantify plasma time of peak concentration (Tmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.	Period 1 pre-dose to maximum Day 14
Secondary	AUCinf of total radioactivity and PF-06821497 in plasma	If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.	Period 1 pre-dose to maximum Day 14
Secondary	t½ of total radioactivity and PF-06821497 in plasma	If data permits, to quantify plasma half-life (t½) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.	Period 1 pre-dose to maximum Day 14
Secondary	AUClast of [14C]PF-06821497 in plasma	To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.	Period 2 pre-dose to maximum Day 5
Secondary	Cmax of [14C]PF-06821497 in plasma	To quantify plasma peak concentration (Cmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.	Period 2 pre-dose to maximum Day 5
Secondary	Tmax of [14C]PF-06821497 in plasma	To quantify plasma time of peak concentration (Tmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.	Period 2 pre-dose to maximum Day 5
Secondary	t½ of [14C]PF-06821497 in plasma	If data permits, to quantify plasma half-life (t½) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.	Period 2 pre-dose to maximum Day 5
Secondary	AUCinf of [14C]PF-06821497 in plasma	If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.	Period 2 pre-dose to maximum Day 5
Secondary	CL of [14C]PF-06821497 in plasma	If data permits, to quantify plasma clearance (CL) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.	Period 2 pre-dose to maximum Day 5
Secondary	Vss of [14C]PF-06821497 in plasma	If data permits, to quantify plasma volume of distribution at steady-state (Vss) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.	Period 2 pre-dose to maximum Day 5
Secondary	Number of participants with treatment emergent clinically significant laboratory abnormalities		Both cohorts from pre-dose to 28 days post-dose
Secondary	Number of participants with treatment emergent clinically significant abnormal ECG measurements		Both cohorts from pre-dose to 28 days post-dose
Secondary	Number of participants with treatment emergent clinically significant abnormal vital measurements		Both cohorts from pre-dose to 28 days post-dose
Secondary	Number of participants with treatment emergent clinically significant abnormal physical examination		Both cohorts from pre-dose to 28 days post-dose
Secondary	Number of participants with treatment-emergent adverse events (AEs) or serious adverse events (SAEs)		Both cohorts from pre-dose to 28 days post-dose

External Links

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