Administered orally

Administered IV

Cmax of total radioactivity in plasma and whole blood.

Tmax of LOXO-305 in plasma.

Tmax of total radioactivity in plasma and whole blood.

t1/2 of LOXO-305 in plasma.

t1/2 of total radioactivity in plasma and whole blood.

CL/F of LOXO-305 in plasma.

Vz/F of LOXO-305 in plasma.

AUC0-inf of plasma LOXO-305 relative to AUC0-inf of plasma total radioactivity, expressed in ratio.

AUC0-inf of whole blood total radioactivity relative to AUC0-inf of plasma total radioactivity, expressed in ratio.

The urine sampling time points from pre-dose through 360 hours post-dose were used to assess this outcome.

The feces sampling time points from the 0 hour (i.e. time of dose) through 360 hours post-dose were used to assess this outcome.

The feces sampling time points from the 0 hour (i.e. time of dose) through 360 hours post-dose were used to assess this outcome.

The urine sampling time points from pre-dose through 360 hours post-dose were used to assess this outcome.

The metabolic profile of LOXO-305 following a single oral dose of [14C]-LOXO-305 was done to assess the presence of LOXO-305 and various metabolites (M1 to M4, M11, M12, M15 to M22) in plasma using high-performance liquid chromatography with radiochemical detection. Metabolites are identified by comparison with known standards (when available) and/or by liquid chromatography/tandem mass spectrometry analysis. The presence of any metabolite in a given matrix is indicated as '1' and absence from that matrix is indicated as '0'.

The metabolic profile of LOXO-305 following a single oral dose of [14C]-LOXO-305 was done to assess the presence of LOXO-305 and various metabolites (M1 to M4, M11, M12, M15 to M22) in urine using high-performance liquid chromatography with radiochemical detection. Metabolites are identified by comparison with known standards (when available) and/or by liquid chromatography/tandem mass spectrometry analysis. The presence of any metabolite in a given matrix is indicated as '1' and absence from that matrix is indicated as '0'.

The metabolic profile of LOXO-305 following a single oral dose of [14C]-LOXO-305 was done to assess the presence of LOXO-305 and various metabolites (M1 to M4, M11, M12, M15 to M22) in feces using high-performance liquid chromatography with radiochemical detection. Metabolites are identified by comparison with known standards (when available) and/or by liquid chromatography/tandem mass spectrometry analysis. The presence of any metabolite in a given matrix is indicated as '1' and absence from that matrix is indicated as '0'.

AUC0-inf of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

AUC0-inf of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

AUC0-inf of total radioactivity in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

AUC0-t of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

AUC0-t of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

AUC0-t of Total Radioactivity in Plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

Cmax of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

Cmax of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

Cmax of Total Radioactivity in Plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

Tmax of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

Tmax of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

Tmax of Total Radioactivity in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

t1/2 of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

t1/2 of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

t1/2 of Total Radioactivity in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

CL/F of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

Vz/F of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

The absolute bioavailability expressed in ratio was calculated using the formula= AUC0-inf (oral) x Dose (IV) divided by AUC0-inf (IV) x Dose (oral) . The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

CL of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

Vz of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

Vss of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

CLR of [14C]-LOXO-305 in urine collection. The urine sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

Total of all reporting groups

AUC0-inf of total radioactivity in plasma and whole blood.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-t of LOXO-305 in plasma.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-t of total radioactivity in plasma and whole blood.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Cmax of LOXO-305 in plasma.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Cmax of total radioactivity in plasma and whole blood.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Tmax of LOXO-305 in plasma.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Tmax of total radioactivity in plasma and whole blood.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

t1/2 of LOXO-305 in plasma.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

t1/2 of total radioactivity in plasma and whole blood.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

CL/F of LOXO-305 in plasma.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Vz/F of LOXO-305 in plasma.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-inf of plasma LOXO-305 relative to AUC0-inf of plasma total radioactivity, expressed in ratio.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-inf of whole blood total radioactivity relative to AUC0-inf of plasma total radioactivity, expressed in ratio.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The urine sampling time points from pre-dose through 360 hours post-dose were used to assess this outcome.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The feces sampling time points from the 0 hour (i.e. time of dose) through 360 hours post-dose were used to assess this outcome.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The feces sampling time points from the 0 hour (i.e. time of dose) through 360 hours post-dose were used to assess this outcome.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The urine sampling time points from pre-dose through 360 hours post-dose were used to assess this outcome.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The metabolic profile of LOXO-305 following a single oral dose of [14C]-LOXO-305 was done to assess the presence of LOXO-305 and various metabolites (M1 to M4, M11, M12, M15 to M22) in plasma using high-performance liquid chromatography with radiochemical detection. Metabolites are identified by comparison with known standards (when available) and/or by liquid chromatography/tandem mass spectrometry analysis. The presence of any metabolite in a given matrix is indicated as '1' and absence from that matrix is indicated as '0'.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The metabolic profile of LOXO-305 following a single oral dose of [14C]-LOXO-305 was done to assess the presence of LOXO-305 and various metabolites (M1 to M4, M11, M12, M15 to M22) in urine using high-performance liquid chromatography with radiochemical detection. Metabolites are identified by comparison with known standards (when available) and/or by liquid chromatography/tandem mass spectrometry analysis. The presence of any metabolite in a given matrix is indicated as '1' and absence from that matrix is indicated as '0'.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The metabolic profile of LOXO-305 following a single oral dose of [14C]-LOXO-305 was done to assess the presence of LOXO-305 and various metabolites (M1 to M4, M11, M12, M15 to M22) in feces using high-performance liquid chromatography with radiochemical detection. Metabolites are identified by comparison with known standards (when available) and/or by liquid chromatography/tandem mass spectrometry analysis. The presence of any metabolite in a given matrix is indicated as '1' and absence from that matrix is indicated as '0'.

All part 1 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-inf of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-inf of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-inf of total radioactivity in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-t of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-t of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

AUC0-t of Total Radioactivity in Plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Cmax of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Cmax of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Cmax of Total Radioactivity in Plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Tmax of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Tmax of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Tmax of Total Radioactivity in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

t1/2 of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

t1/2 of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

t1/2 of Total Radioactivity in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

CL/F of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Vz/F of LOXO-305 in plasma. The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The absolute bioavailability expressed in ratio was calculated using the formula= AUC0-inf (oral) x Dose (IV) divided by AUC0-inf (IV) x Dose (oral) . The sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

CL of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Vz of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Vss of [14C]-LOXO-305 in plasma. The sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

CLR of [14C]-LOXO-305 in urine collection. The urine sampling time points from pre-IV dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The urine sampling time points from pre-oral dose through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

The Feces sampling time points from the 0 hour (i.e. time of oral dose) through 192 hours post-IV dose were used to assess this outcome.

All part 2 participants who received [14C]-LOXO-305 and had at least 1 quantifiable PK concentration, and for whom at least 1 PK parameter was computed. Participants were excluded from the analysis if they had an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).

Participants received:

a single dose of 200 mg LOXO-305 administered as 2×100 mg oral tablets followed 2 hours later by a single dose of less than 100 μg of [14C]-LOXO-305 (approximately 1 microcurie radioactivity) administered as an IV push over approximately 2 minutes.