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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

Cmax is defined as maximum plasma concentration. The determination method of Cmax was observing directly from data.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the PF-06895571 PK parameters of interest.

Cmax is defined as maximum plasma concentration. The determination method of Cmax was observing directly from data.

Analysis population included all participants treated who had at least one of the PF-06895571 PK parameters of interest.

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.

Analysis population included all participants treated who had at least one of the PF-06895571 PK parameters of interest.

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.

Analysis population included all participants treated who had at least one of the PF-06895571 PK parameters of interest.

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.

Analysis population included all participants treated who had at least one of the PF-06895571 PK parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

Cmax is defined as maximum plasma concentration. The determination method of Cmax was observing directly from data.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the PF-06895571 PK parameters of interest.

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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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.

Analysis population included all participants treated who had at least one of the PF-06895571 PK parameters of interest and at least one of the 14C parameters of interest.

%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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

%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.

Analysis population included all participants treated who had at least one of the 14C parameters of interest.

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].

Analysis population included all participants treated who had at least one of the 14C parameters of interest.