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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04866225
Other study ID # C2541007
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 11, 2021
Est. completion date August 6, 2021

Study information

Verified date October 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of [14C]PF-06865571 following oral administration; and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-06865571 following oral administration of unlabeled PF-06865571 and IV administration of [14C]PF-06865571.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date August 6, 2021
Est. primary completion date July 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Male participants, 18 to 60 years of age, inclusive, at the time of signing the informed consent document. - Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests. - Participants who are nonsmoking for at least 3 months at the time of signing the informed consent document. - BMI of 17.5 to 30.4 kg/m2, inclusive; and a total body weight >50 kg (110 lb). Exclusion Criteria: - Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). - History of irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation, defined by less than 1 bowel movement on average per 2 days, or lactose intolerance. - History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg,or HCVAb. Hepatitis B vaccination is allowed. - History of SARS-CoV-2 PCR or antibody (eg, IgG, IgM, etc) positive result would necessitate accompanying history of asymptomatic state for at least 6 months prior to screening. - Use of prescription or nonprescription drugs. - Previous administration with an unapproved drug within 60 days preceding the first dose of study intervention used in this study. - A positive urine drug test. - A positive urine cotinine test. - A positive COVID-19 (SARS-CoV-2) PCR test. - Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral [14C]PF-06865571
Oral radiolabeled PF-06865571
Oral PF-06865571
Oral PF-06865571
IV [14C]PF-06865571
IV radiolabeled PF-06865571

Locations

Country Name City State
United States Covance 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, 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 radiolabeled PF-06865571. Period 1, Pre-dose to maximum Day 21.
Primary Amount (% of administered dose) of radiolabeled PF-06865571 in plasma. To determine the amount of radiolabeled PF-06865571 in plasma as the % of the administered dose. Period 1, Pre-dose to Day 6.
Primary Amount of metabolites of radiolabeled PF-06865571 (% of administered dose) in plasma. To determine the amount of metabolites of radiolabeled PF-06865571 in plasma as the % of the administered dose. Period 1, Pre-dose to Day 6.
Primary Amount (% of administered dose) of radiolabeled PF-06865571 in urine. To determine the amount of radiolabeled PF-06865571 in urine as a % of administered dose. Period 1, Pre-dose to maximum Day 21.
Primary Amount of metabolites of radiolabeled PF-06865571 (% of administered dose) in urine. To determine the amount of metabolites of radiolabeled PF-06865571 in urine as a % of administered dose. Period 1, Pre-dose to maximum Day 21.
Primary Amount (% of administered dose) of radiolabeled PF-06865571 in feces. To determine the amount of radiolabeled PF-06865571 in feces as a % of administered dose. Period 1, Pre-dose to maximum Day 21.
Primary Amount of metabolites of radiolabeled PF-06865571 (% of administered dose) in feces. To determine the amount of metabolites of radiolabeled PF-06865571 in feces as a % of administered dose. Period 1, Pre-dose to maximum Day 21.
Secondary AUClast of oral radiolabeled PF-06865571 in plasma Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radiolabeled PF-06865571 following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary Cmax of oral radiolabeled PF-06865571 in plasma Maximum plasma concentration of radiolabeled PF-06865571 following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary Tmax of oral radiolabeled PF-06865571 in plasma Time to Cmax following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary AUCinf of oral radiolabeled PF-06865571 in plasma (if data permit) Area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary t1/2 of oral radiolabeled PF-06865571 in plasma (if data permit) Terminal elimination half-life following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary AUClast of radioactivity in plasma Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radioactivity following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary Cmax of radioactivity in plasma Maximum plasma concentration of radioactivity following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary Tmax of radioactivity PF-06865571 in plasma Time to Cmax following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary AUCinf of radioactivity in plasma (if data permit) Area under the plasma radioactivity concentration-time profile from time zero extrapolated to infinite time following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary t1/2 of radioactivity in plasma (if data permit) Terminal elimination half-life following administration of a single oral dose of radiolabeled PF-06865571. Period 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose
Secondary AUClast of intravenous radiolabeled PF-06865571 in plasma Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radiolabeled PF-06865571 following administration of a single intravenous dose of radiolabeled PF-06865571. Period 2: Pre-dose, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose
Secondary Cmax of intravenous radiolabeled PF-06865571 in plasma Maximum plasma concentration of radiolabeled PF-06865571 following administration of a single intravenous dose of radiolabeled PF-06865571. Period 2: Pre-dose, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose
Secondary Tmax of intravenous radiolabeled PF-06865571 in plasma Time to Cmax following administration of a single intravenous dose of radiolabeled PF-06865571. Period 2: Pre-dose, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose
Secondary AUCinf of intravenous radiolabeled PF-06865571 in plasma (if data permit) Area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single intravenous dose of radiolabeled PF-06865571. Period 2: Pre-dose, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose
Secondary t1/2 of intravenous radiolabeled PF-06865571 in plasma (if data permit) Terminal elimination half-life following administration of a single intravenous dose of radiolabeled PF-06865571. Period 2: Pre-dose, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose
Secondary CL of intravenous radiolabeled PF-06865571 in plasma (if data permit) Systemic clearance following administration of a single intravenous dose of radiolabeled PF-06865571. Period 2: Pre-dose, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose
Secondary Vss of intravenous radiolabeled PF-06865571 in plasma (if data permit) Steady-state volume of distribution following administration of a single intravenous dose of radiolabeled PF-06865571. Period 2: Pre-dose, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose
Secondary Absolute oral bioavailability of PF-06865571 Dose-normalized plasma AUCinf (if data permit, otherwise AUClast) following oral unlabeled PF-06865571 compared to IV microtracer PF-06865571 in Period 2. Period 2: Pre-dose up to 48 hours post-dose
Secondary Fraction of the dose absorbed (Fa) for oral PF-06865571 Total urinary radioactivity following oral administration of radiolabeled PF-06865571 in Period 1 and IV microtracer administration of PF-06865571 in Period 2. Pre-dose up to 48 hours post-dose
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