Healthy ParticipantsPhase 1NCT04866225

A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.

A Phase 1 study testing Oral [14C]PF-06865571, Oral PF-06865571 and IV [14C]PF-06865571 in people with Healthy Participants, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Oral [14C]PF-06865571, Oral PF-06865571 and IV [14C]PF-06865571
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 11 May 2021to 6 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Labcorp Clinical Research Unit
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE EXTENT OF EXCRETION, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06865571 USING A 14C-MICROTRACER APPROACH

Conditions: Healthy Participants
Being tested: Oral [14C]PF-06865571, Oral PF-06865571, IV [14C]PF-06865571
Keywords: ADME

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04866225
Study group	Role	What they receive
Study arm	Experimental	One arm of healthy male participants administered a single oral dose of [14C]PF-06865571; followed by a single dose of unlabeled PF-06865571, and IV administration of [14C]PF-06865571 three hours later. Receives: Drug: Oral [14C]PF-06865571; Drug: Oral PF-06865571; Drug: IV [14C]PF-06865571

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Recovery of Radioactivity in Urine as Percentage of Total Radioactive Dose of PF-06865571 Administered
The total recovery of radioactivity in urine was listed and summarized using descriptive statistics. In this outcome measure, the percentages of dose excreted in urine in Period 1 and Period 2 were reported.
Measured: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3
Total Recovery of Radioactivity in Feces as Percentage of Total Radioactive Dose of PF-06865571 Administered
The total recovery of radioactivity in feces was listed and summarized using descriptive statistics. In this outcome measure, the percentages of dose excreted in feces in Period 1 and Period 2 were reported.
Measured: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3
Total Recovery of Radioactivity in Total Excreta (Urine + Feces) as Percentage of Total Radioactive Dose of PF-06865571 Administered
The total recovery of radioactivity in the combination of urine and feces was listed and summarized using descriptive statistics. In this outcome measure, the percentages of dose excreted in total excreta (urine + feces) in Period 1 and Period 2 were reported.
Measured: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3
Relative Abundance (Mean Value) of Radiolabeled PF-06865571 in Plasma in Period 1
Plasma samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in plasma, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of radiolabeled PF-06865571 in plasma based on [14C] quantitation was reported. The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Relative Abundance (Mean Value) of Metabolites of Radiolabeled PF-06865571 in Plasma in Period 1
Plasma samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in plasma, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of the metabolites of [14C]PF-06865571 in plasma based on [14C] quantitation was reported. The metabolites included 487, 391, 412, 556, M6 (PF-07822633), M7 (PF-07911964), 584, M1 (PF-06878236), 426, M4 (PF-06887477), 600, M5 (PF-06885984) and M2 (PF-06868609). The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Measured: Period 1: 0, 0.5, 3, 6, 12, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Relative Abundance (Mean Value) of Radiolabeled PF-06865571 in Urine in Period 1
Urine samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in urine, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of radiolabeled PF-06865571 in urine based on [14C] quantitation was reported. The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Measured: Period 1: Day -1 to maximum Day 21
Relative Abundance (Mean Value) of Metabolites of Radiolabeled PF-06865571 in Urine in Period 1
Urine samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in urine, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of the metabolites of [14C]PF-06865571 in urine based on [14C] quantitation was reported. The metabolites included 487, 391, 412, 556, M6 (PF-07822633), M7 (PF-07911964), 584, M1 (PF-06878236), 426, M4 (PF-06887477), 600, M5 (PF-06885984) and M2 (PF-06868609). The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Measured: Period 1: Day -1 to maximum Day 21
Relative Abundance (Mean Value) of Radiolabeled PF-06865571 in Feces in Period 1
Fecal samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in feces, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of radiolabeled PF-06865571 in feces based on [14C] quantitation was reported. The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Measured: Period 1: Day -1 to maximum Day 21
Relative Abundance (Mean Value) of Metabolites of Radiolabeled PF-06865571 in Feces in Period 1
Fecal samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in feces, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of the metabolites of [14C]PF-06865571 in feces based on [14C] quantitation was reported. The metabolites included 487, 391, 412, 556, M6 (PF-07822633), M7 (PF-07911964), 584, M1 (PF-06878236), 426, M4 (PF-06887477), 600, M5 (PF-06885984) and M2 (PF-06868609). The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Measured: Period 1: Day -1 to maximum Day 21

Secondary outcomes (23)

Area Under the Plasma Concentration-time Profile From Time Zero to Time of The Last Quantifiable Concentration (AUClast) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
AUClast is defined as area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast). The determination method of AUClast was linear/log trapezoidal rule.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Maximum Plasma Concentration (Cmax) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Cmax is defined as maximum plasma concentration. The determination method of Cmax was observing directly from data.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Time for Cmax (Tmax) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Tmax is defined as time to reach maximum observed plasma concentration. The determination method of Tmax was observing directly from data as time of first occurrence.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). The determination method of AUCinf was AUClast + (Clast*/ kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel was the terminal phase rate constant.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Terminal Elimination Half-life (t1/2) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Terminal elimination half-life (t1/2) was the time measured for the plasma concentration to decrease by one half. The determination method of t1/2 was loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
AUClast of Oral PF-06865571 in Plasma in Period 1
AUClast is defined as area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast). The determination method of AUClast was linear/log trapezoidal rule.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Cmax of Oral PF-06865571 in Plasma in Period 1
Cmax is defined as maximum plasma concentration. The determination method of Cmax was observing directly from data.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Tmax of Oral PF-06865571 in Plasma in Period 1
Tmax is defined as time to reach maximum observed plasma concentration. The determination method of Tmax was observing directly from data as time of first occurrence.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
AUCinf of Oral PF-06865571 in Plasma in Period 1
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). The determination method of AUCinf was AUClast + (Clast*/ kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel was the terminal phase rate constant.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
t1/2 of Oral PF-06865571 in Plasma in Period 1
Terminal elimination half-life (t1/2) was the time measured for the plasma concentration to decrease by one half. The determination method of t1/2 was loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
AUClast of Intravenous (IV) Radiolabeled PF-06865571 in Plasma in Period 2
AUClast is defined as area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast). The determination method of AUClast was linear/log trapezoidal rule.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Cmax of IV Radiolabeled PF-06865571 in Plasma in Period 2
Cmax is defined as maximum plasma concentration. The determination method of Cmax was observing directly from data.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Tmax of IV Radiolabeled PF-06865571 in Plasma in Period 2
Tmax is defined as time to reach maximum observed plasma concentration. The determination method of Tmax was observing directly from data as time of first occurrence.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
t1/2 of IV Radiolabeled PF-06865571 in Plasma in Period 2
Terminal elimination half-life (t1/2) was the time measured for the plasma concentration to decrease by one half. The determination method of t1/2 was loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
AUCinf of IV Radiolabeled PF-06865571 in Plasma in Period 2
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). The determination method of AUCinf was AUClast + (Clast*/ kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel was the terminal phase rate constant.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Systemic Clearance (CL) of IV Radiolabeled PF-06865571 in Plasma in Period 2
CL is a quantitative measure of the rate at which a drug substance is removed from the body. The determination method of CL was dose/AUCinf.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Steady State Volume of Distribution (Vss) of IV Radiolabeled PF-06865571 in Plasma in Period 2
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Dose-Normalized AUCinf (AUCinf[dn]) of Oral Unlabeled PF-06865571 in Plasma in Period 2
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). AUCinf(dn) is defined as dose normalized (to 1 mg equivalent) AUCinf, which equals to AUCinf/Dose.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
AUCinf(dn) of IV Microtracer of Radiolabeled PF-06865571 in Plasma in Period 2
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). AUCinf(dn) is defined as dose normalized (to 1 mg equivalent) AUCinf, which equals to AUCinf/Dose.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Absolute Oral Bioavailability (F) of Oral Unlabeled and IV Radiolabeled PF-06865571 for Plasma AUCinf(dn) in Period 2
Absolute Oral Bioavailability (F) provided information on the amount of PF-06865571 reaching the systemic circulation. F was estimated as the ratio of adjusted geometric means of dose-normalized AUCinf for oral unlabeled PF-06865571 and IV labeled 14C PF-06865571 in plasma (from Period 2 only) which was equivalent to the following equation: F = [PF-06865571_AUCpo/[14C]PF-06865571_AUCiv]×[ [14C]PF-06865571_Doseiv/ PF-06865571_Dosepo], where PF-06865571_AUCpo = AUCinf(dn) of oral unlabeled PF-06865571, [14C]PF-06865571_AUCiv = AUCinf(dn) of intravenous radiolabeled PF-06865571, [14C]PF-06865571_Doseiv = dose of intravenous radiolabeled PF-06865571, PF-06865571_Dosepo = dose of oral unlabeled PF-06865571.
Measured: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Percentage of Total 14C in Urine Following Oral Administration (%14C_Urine_PO) of Radiolabeled PF-06865571 in Period 1
%14C_Urine_PO is defined as percentage of the radioactive dose administered that is excreted in the urine following oral administration. %14C_Urine_PO = Total 14C_Urine_PO/14C Dosepo × 100, where PO = orally, Total 14C_Urine_PO = total radioactivity excreted into the urine post-dose following oral administration of [14C]PF-06865571, 14C Dosepo = dose of 14C following oral administration of [14C]PF-06865571.
Measured: Period 1: up to 48 hours post-dose (Day 1 to Day 3)
Percentage of Total 14C in Urine Following IV Microtracer Administration (%14C_Urine_IV) of Radiolabeled PF-06865571 in Period 2
%14C_Urine_IV is defined as percentage of the radioactive dose administered that is excreted in the urine following IV administration. %14C_Urine_IV = Total 14C _Urine_IV/14C Doseiv × 100, where IV = intravenous, Total 14C_Urine_IV = total radioactivity excreted into the urine following IV administration of [14C]PF 06865571, 14C Doseiv = dose of 14C following IV administration of [14C]PF 06865571.
Measured: Period 2: up to 48 hours post-dose (Day 1 to Day 3)
Fraction Absorbed (Fa) for Percentage of Excretion of Total 14C in Urine for Oral and IV Radiolabeled PF-06865571
Determination of the Fraction Absorbed (Fa) (obtained from Periods 1 and 2) provided information on the fraction of the total PF-06865571 dose absorbed, regardless of the fate of that dose after absorption (ie, metabolism, degradation, etc). Fa was estimated as the ratio of the adjusted geometric means of % of administered radioactive dose excreted into the urine following oral and IV administration of [14C]PF-06865571 microtracer dose over the same collection time (up to 48 hours post dose) in Periods 1 and 2, respectively: Fa = [% 14C_Urine_PO/% 14C_Urine_IV].
Measured: Period 1 and Period 2: up to 48 hours post-dose (Day 1 to Day 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 20216 Aug 2021

First posted29 Apr 2021
Study start11 May 2021
Primary completion11 Jul 2021
Study completion6 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04866225
Sponsor's protocol ID: C2541007
Status last verified: Feb 2024
First submitted: 19 Apr 2021
Last updated: 31 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE EXTENT OF EXCRETION, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06865571 USING A 14C-MICROTRACER APPROACH
ClinicalTrials.gov ID: NCT04866225
Acronym / sponsor ID: C2541007
Conditions: Healthy Participants
Keywords: ADME
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 11 May 2021 (actual)
Primary completion: 11 Jul 2021 (actual)
Study completion: 6 Aug 2021 (actual)
First posted: 29 Apr 2021 (actual)
Results: Posted 31 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study arm	Experimental	Drug: Oral [14C]PF-06865571, Drug: Oral PF-06865571, Drug: IV [14C]PF-06865571One arm of healthy male participants administered a single oral dose of [14C]PF-06865571; followed by a single dose of unlabeled PF-06865571, and IV administration of [14C]PF-06865571 three hours later.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral [14C]PF-06865571Oral radiolabeled PF-06865571	Drug	Study arm
Oral PF-06865571Oral PF-06865571	Drug	Study arm
IV [14C]PF-06865571IV radiolabeled PF-06865571	Drug	Study arm

Primary outcome

Total Recovery of Radioactivity in Urine as Percentage of Total Radioactive Dose of PF-06865571 Administered
Time frame: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3
The total recovery of radioactivity in urine was listed and summarized using descriptive statistics. In this outcome measure, the percentages of dose excreted in urine in Period 1 and Period 2 were reported.
Total Recovery of Radioactivity in Feces as Percentage of Total Radioactive Dose of PF-06865571 Administered
Time frame: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3
The total recovery of radioactivity in feces was listed and summarized using descriptive statistics. In this outcome measure, the percentages of dose excreted in feces in Period 1 and Period 2 were reported.
Total Recovery of Radioactivity in Total Excreta (Urine + Feces) as Percentage of Total Radioactive Dose of PF-06865571 Administered
Time frame: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3
The total recovery of radioactivity in the combination of urine and feces was listed and summarized using descriptive statistics. In this outcome measure, the percentages of dose excreted in total excreta (urine + feces) in Period 1 and Period 2 were reported.
Relative Abundance (Mean Value) of Radiolabeled PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Plasma samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in plasma, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of radiolabeled PF-06865571 in plasma based on [14C] quantitation was reported. The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Relative Abundance (Mean Value) of Metabolites of Radiolabeled PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 3, 6, 12, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Plasma samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in plasma, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of the metabolites of [14C]PF-06865571 in plasma based on [14C] quantitation was reported. The metabolites included 487, 391, 412, 556, M6 (PF-07822633), M7 (PF-07911964), 584, M1 (PF-06878236), 426, M4 (PF-06887477), 600, M5 (PF-06885984) and M2 (PF-06868609). The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Relative Abundance (Mean Value) of Radiolabeled PF-06865571 in Urine in Period 1
Time frame: Period 1: Day -1 to maximum Day 21
Urine samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in urine, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of radiolabeled PF-06865571 in urine based on [14C] quantitation was reported. The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Relative Abundance (Mean Value) of Metabolites of Radiolabeled PF-06865571 in Urine in Period 1
Time frame: Period 1: Day -1 to maximum Day 21
Urine samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in urine, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of the metabolites of [14C]PF-06865571 in urine based on [14C] quantitation was reported. The metabolites included 487, 391, 412, 556, M6 (PF-07822633), M7 (PF-07911964), 584, M1 (PF-06878236), 426, M4 (PF-06887477), 600, M5 (PF-06885984) and M2 (PF-06868609). The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Relative Abundance (Mean Value) of Radiolabeled PF-06865571 in Feces in Period 1
Time frame: Period 1: Day -1 to maximum Day 21
Fecal samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in feces, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of radiolabeled PF-06865571 in feces based on [14C] quantitation was reported. The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.
Relative Abundance (Mean Value) of Metabolites of Radiolabeled PF-06865571 in Feces in Period 1
Time frame: Period 1: Day -1 to maximum Day 21
Fecal samples were analyzed for radiolabeled PF-06865571 and its metabolites. [14C]PF-06865571 and the major metabolites in feces, after oral administration of 300 mg [14C]PF-06865571 were identified. In this outcome measure, relative abundance of the metabolites of [14C]PF-06865571 in feces based on [14C] quantitation was reported. The metabolites included 487, 391, 412, 556, M6 (PF-07822633), M7 (PF-07911964), 584, M1 (PF-06878236), 426, M4 (PF-06887477), 600, M5 (PF-06885984) and M2 (PF-06868609). The measure type was the mean value based on pooled sampling, which means blood samples from the 6 participants were pooled together and then analyzed as 1 sample, thus the confidence interval could not be calculated. Therefore, "Number" is selected as the Measure Type.

23 secondary outcomes

Area Under the Plasma Concentration-time Profile From Time Zero to Time of The Last Quantifiable Concentration (AUClast) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Maximum Plasma Concentration (Cmax) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Time for Cmax (Tmax) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Terminal Elimination Half-life (t1/2) of Total Radioactivity of [14C]PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
AUClast of Oral PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Cmax of Oral PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
Tmax of Oral PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
AUCinf of Oral PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
t1/2 of Oral PF-06865571 in Plasma in Period 1
Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6)
AUClast of Intravenous (IV) Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Cmax of IV Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Tmax of IV Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
t1/2 of IV Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
AUCinf of IV Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Systemic Clearance (CL) of IV Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Steady State Volume of Distribution (Vss) of IV Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Dose-Normalized AUCinf (AUCinf[dn]) of Oral Unlabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
AUCinf(dn) of IV Microtracer of Radiolabeled PF-06865571 in Plasma in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Absolute Oral Bioavailability (F) of Oral Unlabeled and IV Radiolabeled PF-06865571 for Plasma AUCinf(dn) in Period 2
Time frame: Period 2: -3, 0, 0.08, 0.17, 0.25, 0.5, 0.75, 1, 3, 6, 9, 13, 21, 33 and 45 hours post-dose (Day 1 to Day 3)
Percentage of Total 14C in Urine Following Oral Administration (%14C_Urine_PO) of Radiolabeled PF-06865571 in Period 1
Time frame: Period 1: up to 48 hours post-dose (Day 1 to Day 3)
Percentage of Total 14C in Urine Following IV Microtracer Administration (%14C_Urine_IV) of Radiolabeled PF-06865571 in Period 2
Time frame: Period 2: up to 48 hours post-dose (Day 1 to Day 3)
Fraction Absorbed (Fa) for Percentage of Excretion of Total 14C in Urine for Oral and IV Radiolabeled PF-06865571
Time frame: Period 1 and Period 2: up to 48 hours post-dose (Day 1 to Day 3)

Results and safety

Results posted to the registry on 31 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1:[14C]PF-06865571 300 mg Oral; Period 2:PF-06865571 300 mg Oral & [14C]PF-06865571 100 μg IV	6	6

Primary outcome: Total Recovery of Radioactivity in Urine as Percentage of Total Radioactive Dose of PF-06865571 Administered

Time frame: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3. Mean (Standard Deviation). Unit: Percentage of Dose

Measure	[14C]PF-06865571 300 mg Oral n = 6	PF-06865571 300 mg Oral & [14C]PF-06865571 100 μg IV n = 6
Value	48.9 (16.3)	51.5 (15.8)

Population analysed: Analysis population included all participants who received 1 dose of \[14C\]PF-06865571 and who have evaluable total radioactivity concentration (urinary and fecal) data and who had no protocol deviations or AEs (such as vomiting of the dose, diarrhoea or severe constipation) that may have affected the extent of excretion analysis.

Primary outcome: Total Recovery of Radioactivity in Feces as Percentage of Total Radioactive Dose of PF-06865571 Administered

Time frame: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3. Mean (Standard Deviation). Unit: Percentage of Dose

Measure	[14C]PF-06865571 300 mg Oral n = 6	PF-06865571 300 mg Oral & [14C]PF-06865571 100 μg IV n = 6
Value	30.1 (2.9)	18.8 (3.3)

Primary outcome: Total Recovery of Radioactivity in Total Excreta (Urine + Feces) as Percentage of Total Radioactive Dose of PF-06865571 Administered

Time frame: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3. Mean (Standard Deviation). Unit: Percentage of Dose

Measure	[14C]PF-06865571 300 mg Oral n = 6	PF-06865571 300 mg Oral & [14C]PF-06865571 100 μg IV n = 6
Value	79.0 (16.7)	70.3 (15.1)

Primary outcome: Relative Abundance (Mean Value) of Radiolabeled PF-06865571 in Plasma in Period 1

Time frame: Period 1: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose (Day 1 to Day 6). Number. Unit: Percentage of Radioactivity in Plasma

Measure	[14C]PF-06865571 300 mg Oral n = 6
Value	43.8

Population analysed: Analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: For Period 1, adverse events were assessed from Baseline up to Day 21. For Period 2, adverse events were assessed from Baseline up to Day 21, followed by one follow-up phone call for each participant which occurred at least 28 days and up to 35 days after the last dose of PF-06865571.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
[14C] PF-06865571 300 mg Oral	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
PF-06865571 300 mg Oral & [14C] PF-06865571 100 μg IV	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oral [14C]PF-06865571, Oral PF-06865571 and IV [14C]PF-06865571 in people with Healthy Participants, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Recovery of Radioactivity in Urine as Percentage of Total Radioactive Dose of PF-06865571 Administered (time frame: Period 1: Day -1 to maximum Day 21; Period 2: Day 1 to maximum Day 3). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04866225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.