Trial Outcomes & Findings for A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteers (NCT NCT06840769)

NCT ID: NCT06840769

Last Updated: 2025-05-04

Results Overview

Number of treatment-emergent adverse events (TEAEs) collected up to 24 h post-dose.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 50 participants
• Primary outcome timeframe: From screening visit (day of informed consent signature) up to 24 h after the investigational medicinal product administration (a maximum of 21 days)
• Results posted on: 2025-05-04

Participant Flow

Participants were recruited at the Phase I Unit from 12 June 2023 to 14 October 2023 and enrolled in the study from 17 June 2023 to 16 October 2023.

Fifty (50) subjects were included in the study and received the treatment as planned.

Participant milestones

Measure	Study Part A - Cohort 1 - Akynzeo 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Overall Study STARTED	10	10	10	10	10
Overall Study COMPLETED	9	10	10	10	10
Overall Study NOT COMPLETED	1	0	0	0	0

Reasons for withdrawal

Measure	Study Part A - Cohort 1 - Akynzeo 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Overall Study Withdrawal by Subject	1	0	0	0	0

Baseline Characteristics

A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteers

Baseline characteristics by cohort

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.	Total n=50 Participants Total of all reporting groups
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	46 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	31.7 years STANDARD_DEVIATION 8.9 • n=5 Participants	40.7 years STANDARD_DEVIATION 8.2 • n=7 Participants	38.9 years STANDARD_DEVIATION 13.2 • n=5 Participants	37.9 years STANDARD_DEVIATION 10.8 • n=4 Participants	38.1 years STANDARD_DEVIATION 13.5 • n=21 Participants	37.5 years STANDARD_DEVIATION 11.1 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	20 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	30 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Region of Enrollment Switzerland	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	10 participants n=21 Participants	10 participants n=8 Participants
Body weight	65.94 kilograms STANDARD_DEVIATION 9.50 • n=5 Participants	69.83 kilograms STANDARD_DEVIATION 15.15 • n=7 Participants	71.98 kilograms STANDARD_DEVIATION 13.16 • n=5 Participants	75.20 kilograms STANDARD_DEVIATION 11.24 • n=4 Participants	71.30 kilograms STANDARD_DEVIATION 11.66 • n=21 Participants	70.85 kilograms STANDARD_DEVIATION 12.16 • n=8 Participants
Height	171.0 centimeters STANDARD_DEVIATION 8.1 • n=5 Participants	168.0 centimeters STANDARD_DEVIATION 9.3 • n=7 Participants	170.1 centimeters STANDARD_DEVIATION 8.4 • n=5 Participants	174.0 centimeters STANDARD_DEVIATION 10.4 • n=4 Participants	169.4 centimeters STANDARD_DEVIATION 9.1 • n=21 Participants	170.5 centimeters STANDARD_DEVIATION 9.0 • n=8 Participants
Body mass index	22.46 kilograms/square meters STANDARD_DEVIATION 2.20 • n=5 Participants	24.49 kilograms/square meters STANDARD_DEVIATION 3.36 • n=7 Participants	24.69 kilograms/square meters STANDARD_DEVIATION 2.65 • n=5 Participants	24.74 kilograms/square meters STANDARD_DEVIATION 2.26 • n=4 Participants	24.83 kilograms/square meters STANDARD_DEVIATION 3.42 • n=21 Participants	24.24 kilograms/square meters STANDARD_DEVIATION 2.86 • n=8 Participants

PRIMARY outcome

Timeframe: From screening visit (day of informed consent signature) up to 24 h after the investigational medicinal product administration (a maximum of 21 days)

Number of treatment-emergent adverse events (TEAEs) collected up to 24 h post-dose.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Number of Treatment-emergent Adverse Events	7 Number of TEAE	4 Number of TEAE	3 Number of TEAE	1 Number of TEAE	4 Number of TEAE

PRIMARY outcome

Timeframe: From screening visit (day of informed consent signature) up to 24 h after the investigational medicinal product administration (a maximum of 21 days)

Number of subjects with treatment-emergent adverse events (TEAEs) collected up to 24 h post-dose.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Number of Subjects With Treatment-emergent Adverse Events	5 Number of subjects with TEAE	3 Number of subjects with TEAE	2 Number of subjects with TEAE	1 Number of subjects with TEAE	4 Number of subjects with TEAE

PRIMARY outcome

Timeframe: From screening visit (day of informed consent signature) up to 24 h after the investigational medicinal product administration (a maximum of 21 days)

Type of treatment-emergent adverse events (TEAEs) collected up to 24 h post-dose.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Type of Treatment-emergent Adverse Events Gastrointestinal disorders	2 Number of TEAE	1 Number of TEAE	0 Number of TEAE	0 Number of TEAE	0 Number of TEAE
Study Part A: Type of Treatment-emergent Adverse Events General disorders and administration site conditions	2 Number of TEAE	2 Number of TEAE	0 Number of TEAE	1 Number of TEAE	0 Number of TEAE
Study Part A: Type of Treatment-emergent Adverse Events Nervous system disorders	2 Number of TEAE	1 Number of TEAE	2 Number of TEAE	0 Number of TEAE	4 Number of TEAE
Study Part A: Type of Treatment-emergent Adverse Events Psychiatric disorders	1 Number of TEAE	0 Number of TEAE	0 Number of TEAE	0 Number of TEAE	0 Number of TEAE
Study Part A: Type of Treatment-emergent Adverse Events Investigations	0 Number of TEAE	0 Number of TEAE	1 Number of TEAE	0 Number of TEAE	0 Number of TEAE

SECONDARY outcome

Timeframe: Screening visit/day -1 (enrolment day)/day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

Systolic blood pressure in mmHg measured after 5 min at rest in sitting position

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Systolic Blood Pressure Screening visit	119.7 mmHg Standard Deviation 9.4	118.8 mmHg Standard Deviation 9.7	122.6 mmHg Standard Deviation 12.5	122.6 mmHg Standard Deviation 12.5	119.1 mmHg Standard Deviation 8.9
Study Part A: Systolic Blood Pressure Day -1 (enrolment day)	113.1 mmHg Standard Deviation 6.2	116.7 mmHg Standard Deviation 6.6	122.0 mmHg Standard Deviation 12.5	122.0 mmHg Standard Deviation 12.5	118.8 mmHg Standard Deviation 9.7
Study Part A: Systolic Blood Pressure Day 1 (treatment day) at pre-administration	112.5 mmHg Standard Deviation 8.2	112.8 mmHg Standard Deviation 12.9	114.2 mmHg Standard Deviation 12.2	114.2 mmHg Standard Deviation 12.2	115.6 mmHg Standard Deviation 10.7
Study Part A: Systolic Blood Pressure Day 1 (treatment day) at the end of administration	107.7 mmHg Standard Deviation 12.3	111.5 mmHg Standard Deviation 8.5	113.6 mmHg Standard Deviation 10.6	113.6 mmHg Standard Deviation 10.6	113.2 mmHg Standard Deviation 13.5
Study Part A: Systolic Blood Pressure Day 1 (treatment day) at 1 h after the end of administration	110.4 mmHg Standard Deviation 8.2	111.7 mmHg Standard Deviation 10.6	113.4 mmHg Standard Deviation 11.9	113.4 mmHg Standard Deviation 11.9	112.3 mmHg Standard Deviation 10.2
Study Part A: Systolic Blood Pressure Day 1 (treatment day) at 2 h after the end of administration	106.6 mmHg Standard Deviation 6.9	109.8 mmHg Standard Deviation 11.6	114.1 mmHg Standard Deviation 10.8	114.1 mmHg Standard Deviation 10.8	112.4 mmHg Standard Deviation 7.6
Study Part A: Systolic Blood Pressure Day 1 (treatment day) at 4 h after the end of administration	108.3 mmHg Standard Deviation 10.5	107.6 mmHg Standard Deviation 9.5	113.8 mmHg Standard Deviation 12.7	113.8 mmHg Standard Deviation 12.7	109.8 mmHg Standard Deviation 9.6
Study Part A: Systolic Blood Pressure Day 1 (treatment day) at 24 h after the end of administration	108.5 mmHg Standard Deviation 8.2	112.9 mmHg Standard Deviation 11.7	116.7 mmHg Standard Deviation 10.8	116.7 mmHg Standard Deviation 10.8	115.8 mmHg Standard Deviation 10.6
Study Part A: Systolic Blood Pressure Final visit (7 days after the treatment)	114.4 mmHg Standard Deviation 9.3	111.1 mmHg Standard Deviation 11.8	116.2 mmHg Standard Deviation 8.7	116.2 mmHg Standard Deviation 8.7	120.5 mmHg Standard Deviation 10.9

SECONDARY outcome

Timeframe: Screening visit/day -1 (enrolment day)/day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

Diastolic blood pressure in mmHg measured after 5 min at rest in sitting position

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Diastolic Blood Pressure Screening visit	72.3 mmHg Standard Deviation 6.5	76.8 mmHg Standard Deviation 6.9	80.4 mmHg Standard Deviation 8.0	80.4 mmHg Standard Deviation 8.0	76.7 mmHg Standard Deviation 7.5
Study Part A: Diastolic Blood Pressure Day -1 (enrolment day)	68.9 mmHg Standard Deviation 8.6	77.7 mmHg Standard Deviation 5.8	76.1 mmHg Standard Deviation 7.0	76.1 mmHg Standard Deviation 7.0	74.8 mmHg Standard Deviation 6.9
Study Part A: Diastolic Blood Pressure Day 1 (treatment day) at pre-administration	72.1 mmHg Standard Deviation 9.0	74.9 mmHg Standard Deviation 9.2	76.0 mmHg Standard Deviation 10.1	76.0 mmHg Standard Deviation 10.1	71.9 mmHg Standard Deviation 10.5
Study Part A: Diastolic Blood Pressure Day 1 (treatment day) at the end of administration	62.4 mmHg Standard Deviation 11.1	71.7 mmHg Standard Deviation 8.3	75.2 mmHg Standard Deviation 10.1	75.2 mmHg Standard Deviation 10.1	70.1 mmHg Standard Deviation 9.3
Study Part A: Diastolic Blood Pressure Day 1 (treatment day) at 1 h after the end of administration	63.9 mmHg Standard Deviation 6.4	73.4 mmHg Standard Deviation 8.3	76.7 mmHg Standard Deviation 8.8	76.7 mmHg Standard Deviation 8.8	72.5 mmHg Standard Deviation 7.2
Study Part A: Diastolic Blood Pressure Day 1 (treatment day) at 2 h after the end of administration	64.5 mmHg Standard Deviation 8.5	72.8 mmHg Standard Deviation 7.3	74.8 mmHg Standard Deviation 11.2	74.8 mmHg Standard Deviation 11.2	71.5 mmHg Standard Deviation 9.2
Study Part A: Diastolic Blood Pressure Day 1 (treatment day) at 4 h after the end of administration	65.9 mmHg Standard Deviation 6.6	68.9 mmHg Standard Deviation 8.8	76.6 mmHg Standard Deviation 9.8	76.6 mmHg Standard Deviation 9.8	70.7 mmHg Standard Deviation 8.5
Study Part A: Diastolic Blood Pressure Day 1 (treatment day) at 24 h after the end of administration	67.0 mmHg Standard Deviation 9.4	72.7 mmHg Standard Deviation 7.9	77.5 mmHg Standard Deviation 8.8	77.5 mmHg Standard Deviation 8.8	73.2 mmHg Standard Deviation 7.7
Study Part A: Diastolic Blood Pressure Final visit (7 days after the treatment)	70.1 mmHg Standard Deviation 7.2	74.4 mmHg Standard Deviation 7.5	77.7 mmHg Standard Deviation 7.1	77.7 mmHg Standard Deviation 7.1	77.4 mmHg Standard Deviation 6.4

SECONDARY outcome

Timeframe: Screening visit/day -1 (enrolment day)/day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

Pulse rate in bpm measured after 5 min at rest in sitting position

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Pulse Rate Screening visit	60.9 Beats/min Standard Deviation 7.3	65.3 Beats/min Standard Deviation 7.8	61.0 Beats/min Standard Deviation 10.5	61.0 Beats/min Standard Deviation 10.5	68.3 Beats/min Standard Deviation 7.3
Study Part A: Pulse Rate Day -1 (enrolment day)	68.4 Beats/min Standard Deviation 8.9	74.9 Beats/min Standard Deviation 8.6	75.6 Beats/min Standard Deviation 11.7	75.6 Beats/min Standard Deviation 11.7	77.7 Beats/min Standard Deviation 8.8
Study Part A: Pulse Rate Day 1 (treatment day) at pre-administration	60.0 Beats/min Standard Deviation 5.6	62.4 Beats/min Standard Deviation 8.6	59.0 Beats/min Standard Deviation 9.4	59.0 Beats/min Standard Deviation 9.4	65.2 Beats/min Standard Deviation 7.2
Study Part A: Pulse Rate Day 1 (treatment day) at the end of administration	58.3 Beats/min Standard Deviation 7.5	64.2 Beats/min Standard Deviation 8.6	59.5 Beats/min Standard Deviation 7.7	59.5 Beats/min Standard Deviation 7.7	62.0 Beats/min Standard Deviation 10.1
Study Part A: Pulse Rate Day 1 (treatment day) at 1 h after the end of administration	59.3 Beats/min Standard Deviation 10.4	62.8 Beats/min Standard Deviation 5.4	59.3 Beats/min Standard Deviation 7.8	59.3 Beats/min Standard Deviation 7.8	62.4 Beats/min Standard Deviation 8.9
Study Part A: Pulse Rate Day 1 (treatment day) at 2 h after the end of administration	56.4 Beats/min Standard Deviation 6.8	61.4 Beats/min Standard Deviation 6.8	58.5 Beats/min Standard Deviation 7.8	58.5 Beats/min Standard Deviation 7.8	62.1 Beats/min Standard Deviation 9.2
Study Part A: Pulse Rate Day 1 (treatment day) at 4 h after the end of administration	56.8 Beats/min Standard Deviation 7.2	62.7 Beats/min Standard Deviation 7.5	56.4 Beats/min Standard Deviation 7.2	56.4 Beats/min Standard Deviation 7.2	62.8 Beats/min Standard Deviation 7.9
Study Part A: Pulse Rate Day 1 (treatment day) at 24 h after the end of administration	58.8 Beats/min Standard Deviation 9.8	65.5 Beats/min Standard Deviation 7.9	60.9 Beats/min Standard Deviation 9.0	60.9 Beats/min Standard Deviation 9.0	67.8 Beats/min Standard Deviation 6.5
Study Part A: Pulse Rate Final visit (7 days after the treatment)	56.8 Beats/min Standard Deviation 8.1	62.9 Beats/min Standard Deviation 6.8	61.5 Beats/min Standard Deviation 7.4	61.5 Beats/min Standard Deviation 7.4	72.3 Beats/min Standard Deviation 10.5

SECONDARY outcome

Timeframe: Screening visit (day of informed consent signature)/final visit (7 days after the treatment)

Body weight in kilograms

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Weight Screening visit	65.94 Kilograms Standard Deviation 9.50	69.83 Kilograms Standard Deviation 15.15	71.98 Kilograms Standard Deviation 13.16	71.98 Kilograms Standard Deviation 13.16	71.30 Kilograms Standard Deviation 11.66
Study Part A: Weight Final visit (7 days after the treatment)	66.68 Kilograms Standard Deviation 9.49	70.08 Kilograms Standard Deviation 14.67	72.44 Kilograms Standard Deviation 13.72	72.44 Kilograms Standard Deviation 13.72	71.40 Kilograms Standard Deviation 11.48

SECONDARY outcome

Timeframe: Screening visit (day of informed consent signature)/final visit (7 days after the treatment)

General appearance, Chest/respiratory, Gastrointestinal, Head, eyes, ears, nose and throat, Heart/cardiovascular, Lymph nodes, Metabolic/endocrine, Musculoskeletal/extremities, Neck (including thyroid), Neurological/psychiatric, Skin/dermatologic systems are checked. Any abnormalities are recorded.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Full Physical Examination Through Apparatus/Systems Check Screening visit · Normal	10 Participants	7 Participants	9 Participants	10 Participants	9 Participants
Study Part A: Full Physical Examination Through Apparatus/Systems Check Screening visit · Abnormal not clinically significant	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Study Part A: Full Physical Examination Through Apparatus/Systems Check Final visit (7 days after the treatment) · Normal	10 Participants	7 Participants	10 Participants	10 Participants	10 Participants
Study Part A: Full Physical Examination Through Apparatus/Systems Check Final visit (7 days after the treatment) · Abnormal not clinically significant	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 2 (24 h after the end of investigational product administration)

General appearance, Chest/respiratory, Heart/cardiovascular, Lymph nodes, Neurologic/psychiatric, Skin/dermatologic systems are checked. Any abnormalities are recorded.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Short Physical Examination Through Apparatus/Systems Check Normal	9 Participants	7 Participants	10 Participants	10 Participants	10 Participants
Study Part A: Short Physical Examination Through Apparatus/Systems Check Abnormal not clinically significant	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening visit/ day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

Heart rate in beats/min recorded in supine position after 5 min at rest

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: ECGs - Heart Rate Screening visit · Normal	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - Heart Rate Screening visit · Abnormal not clinically significant	7 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at pre-administration · Normal	1 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at pre-administration · Abnormal not clinically significant	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at the end of administration · Normal	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at the end of administration · Abnormal not clinically significant	8 Participants	7 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 1 h after the end of administration · Normal	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 1 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	8 Participants	9 Participants	8 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 2 h after the end of administration · Normal	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 2 h after the end of administration · Abnormal not clinically significant	10 Participants	8 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 4 h after the end of administration · Normal	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 4 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	9 Participants	9 Participants	8 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 24 h after the end of administration · Normal	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - Heart Rate Day 1 (treatment day) at 24 h after the end of administration · Abnormal not clinically significant	10 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - Heart Rate Final visit (7 days after the treatment) · Normal	2 Participants	7 Participants	3 Participants	2 Participants	4 Participants
Study Part A: ECGs - Heart Rate Final visit (7 days after the treatment) · Abnormal not clinically significant	8 Participants	3 Participants	7 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Screening visit/ day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

PR interval in ms recorded in supine position after 5 min at rest

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: ECGs - PR Interval Screening visit · Normal	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - PR Interval Screening visit · Abnormal, not clinically significant	7 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at pre-administration · Normal	1 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at pre-administration · Abnormal, not clinically significant	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at the end of administration · Normal	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at the end of administration · Abnormal, not clinically significant	8 Participants	7 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 1 h after the end of administration · Normal	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 1 h after the end of administration · Abnormal, not clinically significant	9 Participants	8 Participants	8 Participants	9 Participants	8 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 2 h after the end of administration · Normal	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 2 h after the end of administration · Abnormal, not clinically significant	10 Participants	8 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 4 h after the end of administration · Normal	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 4 h after the end of administration · Abnormal, not clinically significant	9 Participants	8 Participants	9 Participants	9 Participants	8 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 24 h after the end of administration · Normal	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - PR Interval Day 1 (treatment day) at 24 h after the end of administration · Abnormal, not clinically significant	10 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - PR Interval Final visit (7 days after the treatment) · Normal	2 Participants	7 Participants	3 Participants	2 Participants	4 Participants
Study Part A: ECGs - PR Interval Final visit (7 days after the treatment) · Abnormal, not clinically significant	8 Participants	3 Participants	7 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Screening visit/ day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

RR interval in ms recorded in supine position after 5 min at rest

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: ECGs - RR Interval Screening visit · Normal	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - RR Interval Screening visit · Abnormal, not clinically significant	7 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at pre-administration · Normal	1 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at pre-administration · Abnormal, not clinically significant	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at the end of administration · Normal	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at the end of administration · Abnormal, not clinically significant	8 Participants	7 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 1 h after the end of administration · Normal	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 1 h after the end of administration · Abnormal, not clinically significant	9 Participants	8 Participants	8 Participants	9 Participants	8 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 2 h after the end of administration · Normal	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 2 h after the end of administration · Abnormal, not clinically significant	10 Participants	8 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 4 h after the end of administration · Normal	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 4 h after the end of administration · Abnormal, not clinically significant	9 Participants	8 Participants	9 Participants	9 Participants	8 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 24 h after the end of administration · Normal	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - RR Interval Day 1 (treatment day) at 24 h after the end of administration · Abnormal, not clinically significant	10 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - RR Interval Final visit (7 days after the treatment) · Normal	2 Participants	7 Participants	3 Participants	2 Participants	4 Participants
Study Part A: ECGs - RR Interval Final visit (7 days after the treatment) · Abnormal, not clinically significant	8 Participants	3 Participants	7 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Screening visit/ day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

QRS duration in ms recorded in supine position after 5 min at rest

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: ECGs - QRS Duration Screening visit · Normal	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - QRS Duration Screening visit · Abnormal not clinically significant	7 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at pre-administration · Normal	1 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at pre-administration · Abnormal not clinically significant	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at the end of administration · Normal	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at the end of administration · Abnormal not clinically significant	8 Participants	7 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 1 h after the end of administration · Normal	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 1 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	8 Participants	9 Participants	8 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 2 h after the end of administration · Normal	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 2 h after the end of administration · Abnormal not clinically significant	10 Participants	8 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 4 h after the end of administration · Normal	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 4 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	9 Participants	9 Participants	8 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 24 h after the end of administration · Normal	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - QRS Duration Day 1 (treatment day) at 24 h after the end of administration · Abnormal not clinically significant	10 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QRS Duration Final visit (7 days after the treatment) · Normal	2 Participants	7 Participants	3 Participants	2 Participants	4 Participants
Study Part A: ECGs - QRS Duration Final visit (7 days after the treatment) · Abnormal not clinically significant	8 Participants	3 Participants	7 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Screening visit/ day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

QT interval in ms recorded in supine position after 5 min at rest

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: ECGs - QT Interval Screening visit · Normal	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - QT Interval Screening visit · Abnormal, not clinically significant	7 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at pre-administration · Normal	1 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at pre-administration · Abnormal, not clinically significant	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at the end of administration · Normal	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at the end of administration · Abnormal, not clinically significant	8 Participants	7 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 1 h after the end of administration · Normal	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 1 h after the end of administration · Abnormal, not clinically significant	9 Participants	8 Participants	8 Participants	9 Participants	8 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 2 h after the end of administration · Normal	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 2 h after the end of administration · Abnormal, not clinically significant	10 Participants	8 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 4 h after the end of administration · Normal	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 4 h after the end of administration · Abnormal, not clinically significant	9 Participants	8 Participants	9 Participants	9 Participants	8 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 24 h after the end of administration · Normal	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - QT Interval Day 1 (treatment day) at 24 h after the end of administration · Abnormal, not clinically significant	10 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QT Interval Final visit (7 days after the treatment) · Normal	2 Participants	7 Participants	3 Participants	2 Participants	4 Participants
Study Part A: ECGs - QT Interval Final visit (7 days after the treatment) · Abnormal, not clinically significant	8 Participants	3 Participants	7 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Screening visit/ day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

QTcB interval in ms recorded in supine position after 5 min at rest

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: ECGs - QTcB Interval Screening visit · Normal	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - QTcB Interval Screening visit · Abnormal not clinically significant	7 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at pre-administration · Normal	1 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at pre-administration · Abnormal not clinically significant	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at the end of administration · Normal	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at the end of administration · Abnormal not clinically significant	8 Participants	7 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 1 h after the end of administration · Normal	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 1 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	8 Participants	9 Participants	8 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 2 h after the end of administration · Normal	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 2 h after the end of administration · Abnormal not clinically significant	10 Participants	8 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 4 h after the end of administration · Normal	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 4 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	9 Participants	9 Participants	8 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 24 h after the end of administration · Normal	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - QTcB Interval Day 1 (treatment day) at 24 h after the end of administration · Abnormal not clinically significant	10 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QTcB Interval Final visit (7 days after the treatment) · Normal	2 Participants	7 Participants	3 Participants	2 Participants	4 Participants
Study Part A: ECGs - QTcB Interval Final visit (7 days after the treatment) · Abnormal not clinically significant	8 Participants	3 Participants	7 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Screening visit/ day 1 (treatment day) at pre-administration, at the end of administration and 1, 2, 4, 24 h after the end of administration/final visit (7 days after the treatment)

QTcF interval in ms recorded in supine position after 5 min at rest

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: ECGs - QTcF Interval Screening visit · Abnormal not clinically significant	7 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at pre-administration · Normal	1 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at pre-administration · Abnormal not clinically significant	9 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at the end of administration · Normal	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at the end of administration · Abnormal not clinically significant	8 Participants	7 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 1 h after the end of administration · Normal	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 1 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	8 Participants	9 Participants	8 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 2 h after the end of administration · Normal	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 2 h after the end of administration · Abnormal not clinically significant	10 Participants	8 Participants	8 Participants	8 Participants	8 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 4 h after the end of administration · Normal	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 4 h after the end of administration · Abnormal not clinically significant	9 Participants	8 Participants	9 Participants	9 Participants	8 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 24 h after the end of administration · Normal	0 Participants	4 Participants	2 Participants	3 Participants	5 Participants
Study Part A: ECGs - QTcF Interval Day 1 (treatment day) at 24 h after the end of administration · Abnormal not clinically significant	10 Participants	6 Participants	8 Participants	7 Participants	5 Participants
Study Part A: ECGs - QTcF Interval Final visit (7 days after the treatment) · Normal	2 Participants	7 Participants	3 Participants	2 Participants	4 Participants
Study Part A: ECGs - QTcF Interval Final visit (7 days after the treatment) · Abnormal not clinically significant	8 Participants	3 Participants	7 Participants	8 Participants	6 Participants
Study Part A: ECGs - QTcF Interval Screening visit · Normal	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Screening visit (day of informed consent signature)/final visit (7 days after the treatment)

Leukocytes and leukocyte differential count, erythrocytes, haemoglobin, haematocrit, MCV, MCH, MCHC, thrombocytes, electrolytes (sodium, potassium, calcium, chloride, inorganic phosphorus), enzymes (alkaline phosphatase, γ-GT, AST, ALT), substrates/metabolites (total bilirubin, creatinine, glucose, urea, uric acid, total cholesterol, triglycerides), total proteins, urine chemical analysis (pH, specific weight, appearance, color, nitrites, proteins, glucose, urobilinogen, bilirubin, ketones, hematic pigments, leukocytes), urine sediment (analysis performed only if positive: leukocytes, erythrocytes, flat cells, round cells, crystals, cylinders, mucus, bacteria, glomerular erythrocytes). Any abnormalities are recorded.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Screening visit - blood · Normal	5 Participants	2 Participants	2 Participants	3 Participants	1 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Screening visit - blood · Abnormal not clinically significant	5 Participants	8 Participants	8 Participants	7 Participants	9 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Screening visit - blood · Abnormal clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Screening visit - urine · Normal	3 Participants	3 Participants	4 Participants	3 Participants	2 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Screening visit - urine · Abnormal clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Screening visit - urine · Abnormal not clinically significant	7 Participants	7 Participants	6 Participants	7 Participants	8 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Final visit (7 days after the treatment) - blood · Normal	2 Participants	4 Participants	1 Participants	1 Participants	0 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Final visit (7 days after the treatment) - blood · Abnormal not clinically significant	8 Participants	6 Participants	8 Participants	9 Participants	10 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Final visit (7 days after the treatment) - blood · Abnormal clinically significant	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Final visit (7 days after the treatment) - urine · Normal	3 Participants	3 Participants	3 Participants	4 Participants	3 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Final visit (7 days after the treatment) - urine · Abnormal not clinically significant	7 Participants	7 Participants	7 Participants	6 Participants	7 Participants
Study Part A: Clinical Laboratory Tests (Blood Chemistry, Haematology, Urinalysis) Final visit (7 days after the treatment) - urine · Abnormal clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Maximum plasma concentration measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3)

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Cmax Fosnetupitant	8486.000 ng/mL Standard Deviation 2095.382	8920.000 ng/mL Standard Deviation 1722.892	23650.000 ng/mL Standard Deviation 20971.899	32540.000 ng/mL Standard Deviation 6607.437	37500.000 ng/mL Standard Deviation 11243.270
Study Part A: Cmax Netupitant	767.400 ng/mL Standard Deviation 136.572	893.400 ng/mL Standard Deviation 283.232	1050.100 ng/mL Standard Deviation 260.591	1170.700 ng/mL Standard Deviation 276.310	1382.700 ng/mL Standard Deviation 315.816
Study Part A: Cmax Metabolite M1	23.910 ng/mL Standard Deviation 5.324	22.380 ng/mL Standard Deviation 8.433	22.012 ng/mL Standard Deviation 6.687	21.930 ng/mL Standard Deviation 6.958	22.910 ng/mL Standard Deviation 7.610
Study Part A: Cmax Metabolite M2	135.730 ng/mL Standard Deviation 58.257	150.110 ng/mL Standard Deviation 72.607	102.450 ng/mL Standard Deviation 44.216	118.160 ng/mL Standard Deviation 49.015	146.490 ng/mL Standard Deviation 88.541
Study Part A: Cmax Metabolite M3	46.880 ng/mL Standard Deviation 11.936	48.450 ng/mL Standard Deviation 17.019	46.570 ng/mL Standard Deviation 16.137	47.680 ng/mL Standard Deviation 14.446	52.100 ng/mL Standard Deviation 27.347

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Plasma concentration at the end of the administration measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3)

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: C0 Fosnetupitant	8486.000 ng/mL Standard Deviation 2095.382	8920.000 ng/mL Standard Deviation 1722.892	23650.000 ng/mL Standard Deviation 20971.899	32540.000 ng/mL Standard Deviation 6607.437	33557.000 ng/mL Standard Deviation 15972.519
Study Part A: C0 Netupitant	743.100 ng/mL Standard Deviation 173.921	893.400 ng/mL Standard Deviation 283.232	946.100 ng/mL Standard Deviation 419.234	1019.400 ng/mL Standard Deviation 319.820	596.810 ng/mL Standard Deviation 383.903
Study Part A: C0 Metabolite M1	1.714 ng/mL Standard Deviation 2.229	1.753 ng/mL Standard Deviation 1.969	0.337 ng/mL Standard Deviation 1.066	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000
Study Part A: C0 Metabolite M2	28.150 ng/mL Standard Deviation 10.059	49.121 ng/mL Standard Deviation 34.243	32.300 ng/mL Standard Deviation 22.563	25.680 ng/mL Standard Deviation 11.219	12.706 ng/mL Standard Deviation 6.689
Study Part A: C0 Metabolite M3	6.214 ng/mL Standard Deviation 4.144	6.799 ng/mL Standard Deviation 2.989	0.727 ng/mL Standard Deviation 1.711	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Time to achieve the maximum plasma concentration measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3)

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Tmax Netupitant	0.5 h Interval 0.5 to 2.0	0.5 h Interval 0.5 to 0.5	0.25 h Interval 0.25 to 0.33	0.125 h Interval 0.08 to 0.17	0.08 h Interval 0.08 to 0.17
Study Part A: Tmax Metabolite M1	12 h Interval 2.0 to 24.0	10 h Interval 2.0 to 24.0	12 h Interval 1.5 to 24.0	12 h Interval 4.0 to 24.0	12 h Interval 8.0 to 24.0
Study Part A: Tmax Metabolite M2	2 h Interval 2.0 to 4.0	2 h Interval 1.5 to 3.0	2.5 h Interval 0.33 to 3.0	2 h Interval 1.5 to 3.0	1.75 h Interval 1.5 to 4.0
Study Part A: Tmax Metabolite M3	24 h Interval 12.0 to 24.0	24 h Interval 2.0 to 24.0	24 h Interval 12.0 to 24.0	24 h Interval 12.0 to 24.0	24 h Interval 12.0 to 24.0
Study Part A: Tmax Fosnetupitant	0.5 h Interval 0.5 to 0.5	0.5 h Interval 0.5 to 0.5	0.25 h Interval 0.25 to 0.3	0.08 h Interval 0.08 to 0.08	0.05 h Interval 0.033 to 0.08

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Last measurable plasma concentration measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3)

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Clast Fosnetupitant	79.780 ng/mL Standard Deviation 71.819	49.410 ng/mL Standard Deviation 35.149	97.140 ng/mL Standard Deviation 122.226	45.620 ng/mL Standard Deviation 28.083	34.330 ng/mL Standard Deviation 16.176
Study Part A: Clast Netupitant	149.150 ng/mL Standard Deviation 111.842	122.490 ng/mL Standard Deviation 40.233	136.340 ng/mL Standard Deviation 39.724	123.740 ng/mL Standard Deviation 28.843	137.270 ng/mL Standard Deviation 66.827
Study Part A: Clast Metabolite M1	21.150 ng/mL Standard Deviation 3.876	20.380 ng/mL Standard Deviation 7.875	20.532 ng/mL Standard Deviation 6.667	19.990 ng/mL Standard Deviation 5.977	21.440 ng/mL Standard Deviation 7.826
Study Part A: Clast Metabolite M2	20.090 ng/mL Standard Deviation 10.519	18.850 ng/mL Standard Deviation 7.890	14.534 ng/mL Standard Deviation 4.789	18.770 ng/mL Standard Deviation 5.515	17.067 ng/mL Standard Deviation 7.953
Study Part A: Clast Metabolite M3	46.370 ng/mL Standard Deviation 12.315	48.020 ng/mL Standard Deviation 17.273	44.960 ng/mL Standard Deviation 15.634	47.080 ng/mL Standard Deviation 14.763	52.060 ng/mL Standard Deviation 27.374

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Time of last measurable plasma concentration measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3)

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Tlast Fosnetupitant	0.83 h Standard Deviation 0.118	0.95 h Standard Deviation 0.23	1.075 h Standard Deviation 1.048	0.6 h Standard Deviation 0.316	0.633 h Standard Deviation 0.35
Study Part A: Tlast Netupitant	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0
Study Part A: Tlast Metabolite M1	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0
Study Part A: Tlast Metabolite M2	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0
Study Part A: Tlast Metabolite M3	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0	24 h Standard Deviation 0

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Area under the concentration-time curve from time zero to time of last measurable plasma concentration measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3)

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: AUC0-t Fosnetupitant	3217.286 h x ng/mL Standard Deviation 780.235	3374.275 h x ng/mL Standard Deviation 658.088	4807.383 h x ng/mL Standard Deviation 4537.620	3662.088 h x ng/mL Standard Deviation 630.455	3839.681 h x ng/mL Standard Deviation 859.368
Study Part A: AUC0-t Netupitant	5404.315 h x ng/mL Standard Deviation 1227.399	5232.178 h x ng/mL Standard Deviation 1119.310	5792.056 h x ng/mL Standard Deviation 1520.649	5344.307 h x ng/mL Standard Deviation 1385.625	5656.305 h x ng/mL Standard Deviation 1998.286
Study Part A: AUC0-t Metabolite M1	468.997 h x ng/mL Standard Deviation 113.819	456.214 h x ng/mL Standard Deviation 173.046	436.089 h x ng/mL Standard Deviation 142.089	426.440 h x ng/mL Standard Deviation 122.749	447.497 h x ng/mL Standard Deviation 143.611
Study Part A: AUC0-t Metabolite M2	1234.204 h x ng/mL Standard Deviation 767.496	1260.320 h x ng/mL Standard Deviation 477.244	959.756 h x ng/mL Standard Deviation 382.755	1137.332 h x ng/mL Standard Deviation 331.659	1182.642 h x ng/mL Standard Deviation 560.829
Study Part A: AUC0-t Metabolite M3	833.606 h x ng/mL Standard Deviation 164.142	895.624 h x ng/mL Standard Deviation 304.534	831.375 h x ng/mL Standard Deviation 306.679	826.377 h x ng/mL Standard Deviation 156.114	935.410 h x ng/mL Standard Deviation 441.878

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Area under the plasma concentration-time curve from time zero to 24 h after the administration measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3)

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: AUC0-24 Fosnetupitant	3228.246 h x ng/mL Standard Deviation 781.172	3382.473 h x ng/mL Standard Deviation 657.505	4833.636 h x ng/mL Standard Deviation 4577.777	3668.069 h x ng/mL Standard Deviation 631.004	3844.251 h x ng/mL Standard Deviation 859.498
Study Part A: AUC0-24 Netupitant	5404.315 h x ng/mL Standard Deviation 1227.399	5232.178 h x ng/mL Standard Deviation 1119.310	5792.056 h x ng/mL Standard Deviation 1520.649	5344.307 h x ng/mL Standard Deviation 1385.625	5656.305 h x ng/mL Standard Deviation 1998.286
Study Part A: AUC0-24 Metabolite M1	468.997 h x ng/mL Standard Deviation 113.819	456.214 h x ng/mL Standard Deviation 173.046	436.089 h x ng/mL Standard Deviation 142.089	426.440 h x ng/mL Standard Deviation 122.749	447.497 h x ng/mL Standard Deviation 143.611
Study Part A: AUC0-24 Metabolite M2	1234.204 h x ng/mL Standard Deviation 767.496	1260.320 h x ng/mL Standard Deviation 477.244	959.756 h x ng/mL Standard Deviation 382.755	1137.332 h x ng/mL Standard Deviation 331.659	1182.642 h x ng/mL Standard Deviation 560.829
Study Part A: AUC0-24 Metabolite M3	833.606 h x ng/mL Standard Deviation 164.142	895.624 h x ng/mL Standard Deviation 304.534	831.375 h x ng/mL Standard Deviation 306.679	826.377 h x ng/mL Standard Deviation 156.114	935.410 h x ng/mL Standard Deviation 441.878

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Terminal elimination rate constant, calculated, if feasible, by log-linear regression using at least 3 points, C0 and Cmax excluded and measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3). Calculation was not feasible for M1 and M3, therefore these analytes are not reported in the Outcome Measure Data Table.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Terminal Elimination Rate Constant Fosnetupitant	12.157 1/h Standard Deviation 0.662	11.734 1/h Standard Deviation 0.754	14.979 1/h Standard Deviation 5.582	18.613 1/h Standard Deviation 3.868	19.141 1/h Standard Deviation 5.429
Study Part A: Terminal Elimination Rate Constant Netupitant	0.034 1/h Standard Deviation 0.012	0.034 1/h Standard Deviation 0.007	0.033 1/h Standard Deviation 0.012	0.039 1/h Standard Deviation 0.005	0.032 1/h Standard Deviation 0.014
Study Part A: Terminal Elimination Rate Constant Metabolite M2	0.063 1/h Standard Deviation 0.014	0.061 1/h Standard Deviation 0.018	0.058 1/h Standard Deviation 0.017	0.059 1/h Standard Deviation 0.013	0.061 1/h Standard Deviation 0.015

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Apparent terminal half-life calculated, if feasible, by as ln2/terminal elimination rate constant and measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3). Calculation was not feasible for M1 and M3, therefore these analytes are not reported in the Outcome Measure Data Table.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: t1/2 Netupitant	22.104 h Standard Deviation 7.005	21.356 h Standard Deviation 4.151	25.176 h Standard Deviation 14.727	18.017 h Standard Deviation 2.747	30.061 h Standard Deviation 24.561
Study Part A: t1/2 Metabolite M2	11.538 h Standard Deviation 2.490	12.855 h Standard Deviation 5.985	12.918 h Standard Deviation 4.023	12.468 h Standard Deviation 3.215	12.248 h Standard Deviation 3.863
Study Part A: t1/2 Fosnetupitant	0.057 h Standard Deviation 0.003	0.059 h Standard Deviation 0.004	0.080 h Standard Deviation 0.115	0.039 h Standard Deviation 0.011	0.040 h Standard Deviation 0.017

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Systemic clearance measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3). Calculation was not feasible for M1 and M3, therefore these analytes are not reported in the Outcome Measure Data Table.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Systemic Clearance Netupitant	27219.010 mL/h Standard Deviation 3356.654	28693.446 mL/h Standard Deviation 7660.440	24200.268 mL/h Standard Deviation 6832.625	27596.213 mL/h Standard Deviation 6404.903	26994.542 mL/h Standard Deviation 10531.874
Study Part A: Systemic Clearance Metabolite M2	172324.405 mL/h Standard Deviation 50962.753	162039.804 mL/h Standard Deviation 57537.646	211825.621 mL/h Standard Deviation 68310.261	174034.336 mL/h Standard Deviation 64374.511	182468.624 mL/h Standard Deviation 68658.409
Study Part A: Systemic Clearance Fosnetupitant	61821.940 mL/h Standard Deviation 16436.343	66942.974 mL/h Standard Deviation 12370.822	65171.229 mL/h Standard Deviation 21219.721	65651.064 mL/h Standard Deviation 9975.506	63748.966 mL/h Standard Deviation 13353.411

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Apparent volume of distribution in the post-distribution phase measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3). Calculation was not feasible for M1 and M3, therefore these analytes are not reported in the Outcome Measure Data Table.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: Vz Netupitant	848022.360 mL Standard Deviation 215723.734	872978.816 mL Standard Deviation 264673.002	772482.708 mL Standard Deviation 205893.262	719627.108 mL Standard Deviation 219903.292	944544.565 mL Standard Deviation 311425.672
Study Part A: Vz Metabolite M2	2895427.080 mL Standard Deviation 954908.605	2820832.784 mL Standard Deviation 1000428.130	4109459.426 mL Standard Deviation 2374558.032	3083100.830 mL Standard Deviation 1154481.625	3122087.067 mL Standard Deviation 1170365.896
Study Part A: Vz Fosnetupitant	5129.653 mL Standard Deviation 1631.449	5765.916 mL Standard Deviation 1352.379	4796.595 mL Standard Deviation 1491.027	3728.124 mL Standard Deviation 1263.039	3572.355 mL Standard Deviation 1199.382

SECONDARY outcome

Timeframe: Day 1 (treatment day) at pre-administration, at 2, 5, 10, 15, 20, 30 and 45 min and at 1, 1.5, 2, 3, 4, 8, 12, 24 h after the administration

Mean residence time measured for plasma fosnetupitant, netupitant and its main metabolites (M1, M2 and M3). Calculation was not feasible for M1 and M3, therefore these analytes are not reported in the Outcome Measure Data Table.

Outcome measures

Measure	Study Part A - Cohort 1 - Akynzeo n=10 Participants 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 Participants 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Study Part A: MRT Fosnetupitant	0.253 h Standard Deviation 0.001	0.254 h Standard Deviation 0.002	0.275 h Standard Deviation 0.038	0.109 h Standard Deviation 0.014	0.086 h Standard Deviation 0.014
Study Part A: MRT Netupitant	28.529 h Standard Deviation 9.761	26.760 h Standard Deviation 5.780	33.752 h Standard Deviation 21.148	24.493 h Standard Deviation 3.866	40.753 h Standard Deviation 34.769
Study Part A: MRT Metabolite M2	14.343 h Standard Deviation 2.220	15.895 h Standard Deviation 7.651	16.347 h Standard Deviation 5.492	16.299 h Standard Deviation 3.936	14.975 h Standard Deviation 4.858

Adverse Events

Study Part A - Cohort 1 - Akynzeo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Study Part A - Cohort 1 - Fosnetupitant

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Study Part A - Cohort 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Study Part A - Cohort 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Study Part A - Cohort 4

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study Part A - Cohort 1 - Akynzeo n=10 participants at risk 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min.	Study Part A - Cohort 1 - Fosnetupitant n=10 participants at risk 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min.	Study Part A - Cohort 2 n=10 participants at risk 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min.	Study Part A - Cohort 3 n=10 participants at risk 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min.	Study Part A - Cohort 4 n=10 participants at risk 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min.
Gastrointestinal disorders Constipation	20.0% 2/10 • Number of events 2 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Gastrointestinal disorders Nausea	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
General disorders Fatigue	20.0% 2/10 • Number of events 2 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
General disorders Infusion site pain	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
General disorders Injection site discomfort	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
General disorders Influenza like illness	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Nervous system disorders Presyncope	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Nervous system disorders Headache	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	20.0% 2/10 • Number of events 2 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Nervous system disorders Dysgeusia	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Investigations AST increased	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	10.0% 1/10 • Number of events 1 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).	0.00% 0/10 • The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).

Additional Information

Tulla Spinelli

Helsinn Healthcare SA

Phone: +41.91.985.21.21

Email: Tulla.Spinelli@helsinn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place