| Primary | Period 1: Percent Absolute Oral Bioavailability (%F) for Mobocertinib | Absolute bioavailability (F), defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. Percent Absolute Oral Bioavailability (%F) was calculated as dose of [14C]-mobocertinib intravenous in mg*AUC∞ of mobocertinib (oral)/dose of mobocertinib (oral)* AUC∞ of [14C]-mobocertinib (intravenous)*100. | The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This outcome measure (OM) was planned to be assessed only in Period 1. | Posted | | Geometric Mean | 90% Confidence Interval | percentage bioavailability | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Primary | Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Urine Relative to the Administered Radioactive Dose | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of radioactive dose | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Feces Relative to the Administered Radioactive Dose | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of radioactive dose | | Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2: Amount of Total Radioactivity Excreted in Urine (Ae[UR]) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milligram equivalent (mg eq) | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2: Amount of Total Radioactivity Excreted in Feces (Ae[Fe]) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg eq | | Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2. | Posted | | Mean | Standard Deviation | percentage of radioactive dose | | Day 1: Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2. | Posted | | Mean | Standard Deviation | percentage of radioactive dose | | Day 1: at Pre-dose, 0-24 hours (hrs), 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs; 240-264 hrs, 264-288 hrs, 288-312 hrs, 213-408 hrs and 408-432 hrs | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, Cmax: Maximum Observed Plasma and Whole Blood Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Median | Full Range | hours | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | 14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2: t(1/2): Terminal Disposition Phase Half-life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma and Whole Blood | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUC∞: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | 14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUCt: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time t for Mobocertinib and Its Metabolites (AP32960 and AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, Cmax: Maximum Observed Plasma Radioactivity Concentration Equivalents for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent/milliliter(ng eq/mL) | | Day 1 pre-dose at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, Cmax: Maximum Observed Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent/ gram (ng eq/g) | | Day 1 pre-dose at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) Equivalents for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Median | Full Range | hours | | Day 1 pre-dose at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-Mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Day 1 pre-dose at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUC∞: Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per milliliter | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUC∞: Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per gram | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUClast: Area Under the Plasma Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per milliliter | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUClast: Area Under the Whole Blood Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]- Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per gram | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | 14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUCt : Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per milliliter | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, AUCt : Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram equivalent*hour per gram | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | 14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, Aet1-t2: Amount of Unchanged Drug Excreted in the Urine in Each Collection Interval From t1 to t2 for Mobocertinib and Its Metabolites (AP32960 and AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2. | Posted | | Mean | Standard Deviation | mg | | Day 1: at Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs and 216-240 hrs post dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, CLR: Renal Clearance for Mobocertinib and Its Metabolites (AP32960 and AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter per hour ( L/h) | | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Primary | Period 2, Percentage Change of [14C]-Radioactivity in Whole Blood Relative to Plasma Over the Time for [14C]-Mobocertinib, (Whole Blood : Plasma Partitioning Ratio) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. Here, '0' in the number analyzed field signifies that no participants were evaluable at specified time points. This OM was planned to be assessed only in Period 2. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | At 0.5 hours (hrs), 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 72 hrs, 96 hrs, 120 hrs, 144 hrs, 168 hrs, 192 hrs, 216 hrs and 240 hrs post-dose | | | | ID | Title | Description |
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| OG000 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Secondary | Period 1, Ceoi: Plasma Concentration at the End of Infusion for [14C]-Mobocertinib, and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picograms per milliliter (pg /mL) | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Mobocertinib160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously over 15 minutes, once on Day 1 of Period 1. |
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| Secondary | Period 1, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, Cmax: Maximum Observed Plasma Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral, and [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration | Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration. | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1. | Posted | | Median | Full Range | hours | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
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| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) After Intravenous Administration | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram*hour/ milliliter (pg*hr/mL) | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg*hr/mL | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration | | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram*hour per milliliter (pg*hr/mL) | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Period 1, t(1/2):Terminal Disposition Phase Half-Life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma After Oral, and [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) in Plasma After Intravenous Administration | Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration. | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. |
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| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | | The safety set included all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to 30 days after last dose of study drug in Period 2 (Day 41) | | | | ID | Title | Description |
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| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. | | OG001 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | | The safety set included all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to 30 days after last dose of study drug in Period 2 (Day 41) | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. | | OG001 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | | The safety set included all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to 30 days after last dose of study drug in Period 2 (Day 41) | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. | | OG001 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | | The safety set included all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to 30 days after last dose of study drug in Period 2 (Day 41) | | | | ID | Title | Description |
|---|
| OG000 | Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg | Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1. | | OG001 | [14C]-Mobocertinib 160 mg | [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2. |
| |