Trial Outcomes & Findings for Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers (NCT NCT02792829)

Last Updated: 2019-03-14

Results Overview

Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance liquid chromatography/tandem mass spectrometry (LC-MS/MS) method using a previously validated assay. The lower limit of quantitation (LLOQ) was 0.25 ng/mL. Plasma pharmacokinetics (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-t), which were then summarized as the mean and standard deviation for all participants and expressed as hours·nanogram/milliliter (hr·ng/mL).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Results posted on

2019-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Lenvatinib 11 mg: Suspension+ Capsules (CAP) Participants received lenvatinib 11 mg (milligram), suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11 mg, capsules (1 capsules of 10mg and 1 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: Lenvatinib 11 mg: CAP+ Suspension Participants received lenvatinib 11 mg, capsules (1 capsules of 10mg and 1 capsules of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11 mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2:Lenvatinib 11mg Suspension:5 CAP-Water+2 Cap-Apple Juice Participants received lenvatinib 11mg, suspension in water (prepared using 2 capsule of 4 mg each and 3 capsule of 1 mg each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in apple juice (prepared using 1 capsules of 10mg and 1 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2:Lenvatinib 11mg Suspension:5 CAP-Apple Juice+2 CAP-Water Participants received lenvatinib 11mg, suspension in apple juice (prepared using 2 capsule of 4 mg each and 3 capsule of 1 mg each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2:Lenvatinib 11mg Suspension:2 CAP-Water+5 CAP-Apple Juice Participants received lenvatinib 11mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in apple juice (prepared using 2 capsules of 4 mg each and 3 capsules of 1 mg each) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2:Lenvatinib 11mg Suspension:2 CAP-Apple Juice+5 CAP-Water Participants received lenvatinib 11mg, suspension in apple juice (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in water (prepared using 2 capsules of 4 mg each and 3 capsules of 1 mg) on Day 8 on Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3:Lenvatinib 23mg Suspension Taken at:23 Hours+2 Hours Participants received lenvatinib 11mg, suspension in water taken 23 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg of each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 23mg, suspension in water taken 2 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3:Lenvatinib 23mg Suspension Taken at:2 Hours+23 Hours Participants received lenvatinib 23mg, suspension in water taken 2 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg of each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 23mg, suspension in water taken 23 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Treatment Period 1 STARTED	10	10	5	5	5	5	10	10
Treatment Period 1 COMPLETED	10	10	5	5	5	5	10	10
Treatment Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0
Wash Out Period STARTED	10	10	5	5	5	5	10	10
Wash Out Period COMPLETED	10	10	5	5	5	5	10	10
Wash Out Period NOT COMPLETED	0	0	0	0	0	0	0	0
Treatment Period 2 STARTED	10	10	5	5	5	5	10	10
Treatment Period 2 COMPLETED	10	9	5	5	4	5	9	8
Treatment Period 2 NOT COMPLETED	0	1	0	0	1	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Lenvatinib 11 mg: CAP+ Suspension Participants received lenvatinib 11 mg, capsules (1 capsules of 10mg and 1 capsules of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11 mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2:Lenvatinib 11mg Suspension:2 CAP-Water+5 CAP-Apple Juice Participants received lenvatinib 11mg, suspension in water (prepared using 1 capsule of 10 mg and 1 capsule of 1 mg) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 11mg, suspension in apple juice (prepared using 2 capsules of 4 mg each and 3 capsules of 1 mg each) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3:Lenvatinib 23mg Suspension Taken at:23 Hours+2 Hours Participants received lenvatinib 11mg, suspension in water taken 23 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg of each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 23mg, suspension in water taken 2 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3:Lenvatinib 23mg Suspension Taken at:2 Hours+23 Hours Participants received lenvatinib 23mg, suspension in water taken 2 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg of each) on Day 1 of Treatment Period 1 followed by a 6-days wash-out period, further followed by lenvatinib 23mg, suspension in water taken 23 hours after preparation (prepared using 2 capsules of 10 mg each and 3 capsules of 1 mg) on Day 8 of Treatment Period 2. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Treatment Period 2 Non compliance with alcohol prohibition	1	0	0	0
Treatment Period 2 Adverse Event	0	1	1	1
Treatment Period 2 Use of proscribed medications	0	0	0	1

Baseline Characteristics

Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: 11 mg Lenvatinib Suspension in Water n=10 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=10 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=5 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=5 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=5 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice) n=5 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=10 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=10 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Total n=60 Participants Total of all reporting groups
Age, Customized 18 to 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	10 Participants n=8 Participants	10 Participants n=24 Participants	60 Participants n=42 Participants
Sex/Gender, Customized Male	9 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	7 Participants n=24 Participants	42 Participants n=42 Participants
Sex/Gender, Customized Female	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	5 Participants n=8 Participants	3 Participants n=24 Participants	18 Participants n=42 Participants

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: The PK Analysis Set was the group of subjects who had sufficient PK data for at least 1 PK parameter to be derived. Subjects with predose lenvatinib concentration \>5% of their own Cmax, and subjects who experienced emesis at or before 2x median tmax were excluded from data analysis for bioavailability.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))	1010 hr·ng/mL Standard Deviation 160	3010 hr·ng/mL Standard Deviation 919	1330 hr·ng/mL Standard Deviation 452	1340 hr·ng/mL Standard Deviation 482	1020 hr·ng/mL Standard Deviation 172	1500 hr·ng/mL Standard Deviation 706	1340 hr·ng/mL Standard Deviation 519	3210 hr·ng/mL Standard Deviation 1040

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: PK analysis set

Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the AUC(0-inf), which were then summarized as the mean and standard deviation for all participants and expressed as hr·ng/mL.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=17 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC(0-inf))	1030 hr·ng/mL Standard Deviation 161	2970 hr·ng/mL Standard Deviation 910	1360 hr·ng/mL Standard Deviation 456	1360 hr·ng/mL Standard Deviation 490	1040 hr·ng/mL Standard Deviation 177	1530 hr·ng/mL Standard Deviation 720	1370 hr·ng/mL Standard Deviation 532	3240 hr·ng/mL Standard Deviation 1050

PRIMARY outcome

Timeframe: Treatment Period 1: Predose up to 24 hours post dose

Population: PK analysis set

Blood samples were collected during each Treatment Period at predose up to 24 hours post dose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the AUC(0-24), which were then summarized as the mean and standard deviation for all participants and expressed as hr·ng/mL.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=8 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24))	804 h·ng/mL Standard Deviation 136	2540 h·ng/mL Standard Deviation 785	1060 h·ng/mL Standard Deviation 377	1050 h·ng/mL Standard Deviation 383	815 h·ng/mL Standard Deviation 136	1150 h·ng/mL Standard Deviation 564	1070 h·ng/mL Standard Deviation 415	2720 h·ng/mL Standard Deviation 858

PRIMARY outcome

Timeframe: Treatment Period 1: Predose up to 72 hours postdose

Population: PK analysis set

Blood samples were collected during each Treatment Period at predose up to 72 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the AUC(0-72), which were then summarized as the mean and standard deviation for all participants and expressed as hr·ng/mL.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Area Under the Plasma Concentration-Time Curve From Zero to 72 Hours (AUC(0-72))	971 hr·ng/mL Standard Deviation 152	2930 hr·ng/mL Standard Deviation 887	1280 hr·ng/mL Standard Deviation 437	1290 hr·ng/mL Standard Deviation 466	987 hr·ng/mL Standard Deviation 164	1430 hr·ng/mL Standard Deviation 668	1290 hr·ng/mL Standard Deviation 500	3130 hr·ng/mL Standard Deviation 1010

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: PK analysis set

Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the CL/F, which were then summarized as the mean and standard deviation for all participants and expressed as liters/hour.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=17 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=8 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Apparent Clearance (CL/F)	10.9 L/hour Standard Deviation 1.61	8.46 L/hour Standard Deviation 2.65	9.34 L/hour Standard Deviation 4.36	9.47 L/hour Standard Deviation 4.45	10.8 L/hour Standard Deviation 1.73	8.70 L/hour Standard Deviation 3.44	9.10 L/hour Standard Deviation 3.07	7.73 L/hour Standard Deviation 2.19

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: PK analysis set

Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the Vz/F, which were then summarized as the mean and standard deviation for all participants and expressed in liters (L).

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=17 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=8 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Apparent Volume of Distribution (Vz/F)	360 Liters Standard Deviation 103	247 Liters Standard Deviation 95.7	301 Liters Standard Deviation 159	296 Liters Standard Deviation 123	356 Liters Standard Deviation 74.0	317 Liters Standard Deviation 131	312 Liters Standard Deviation 122	238 Liters Standard Deviation 122

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: Pharmacokinetic (PK) analysis set

Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which were then summarized as the mean and standard deviation for all participants and expressed as nanograms/milliliter (ng/mL).

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Maximum Concentration (Cmax) of Lenvatinib in Plasma	105 ng/mL Standard Deviation 21.2	358 ng/mL Standard Deviation 128	133 ng/mL Standard Deviation 52.5	126 ng/mL Standard Deviation 44.9	115 ng/mL Standard Deviation 22.9	150 ng/mL Standard Deviation 65.2	138 ng/mL Standard Deviation 61.3	375 ng/mL Standard Deviation 134

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: PK analysis set

Tlag was defined as the time delay between drug administration and the onset of drug absorption. Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of tlag, which were then summarized as the median and full range for all participants and expressed in hours.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Time Prior to the First Measureable Concentration of Lenvatinib (Tlag)	0.00 Hours Interval 0.0 to 0.0	0.00 Hours Interval 0.0 to 0.0	0.00 Hours Interval 0.0 to 0.53	0.00 Hours Interval 0.0 to 0.5	0.00 Hours Interval 0.0 to 0.5	0.00 Hours Interval 0.0 to 0.0	0.00 Hours Interval 0.0 to 0.5	0.00 Hours Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: PK analysis set

Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of tmax, which were then summarized as the median and full range for all participants and expressed in hours.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Time to Maximum Plasma Concentration (Tmax)	2.00 Hours Interval 2.0 to 3.0	2.00 Hours Interval 1.0 to 4.0	3.00 Hours Interval 1.0 to 4.0	3.00 Hours Interval 2.0 to 4.0	2.52 Hours Interval 2.0 to 3.0	3.00 Hours Interval 2.0 to 3.0	2.50 Hours Interval 2.0 to 4.0	2.00 Hours Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)

Population: PK analysis set

Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of t1/2, which were then summarized as the median and full range for all participants and expressed in hours.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Terminal Elimination Phase Half-life (t1/2)	23.1 Hours Standard Deviation 6.15	20.4 Hours Standard Deviation 4.51	22.7 Hours Standard Deviation 6.09	22.4 Hours Standard Deviation 4.67	23.2 Hours Standard Deviation 5.67	25.5 Hours Standard Deviation 4.27	24.1 Hours Standard Deviation 5.05	21.5 Hours Standard Deviation 7.35

PRIMARY outcome

Timeframe: From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days

Population: Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment

Safety assessment consisted on monitoring and recording all treatment-emergent adverse events (TEAEs) and SAEs; as well as laboratory evaluations for hematology, blood chemistry, and urine values; periodic measurement of vital signs, electrocardiograms (ECGs); and physical examinations. A TEAE was defined as an adverse events that: 1) emerged during treatment and up to 7 days from the last treatment, having been absent before treatment or at baseline, 2) reemerged during treatment, having been present at Baseline but stopped before treatment, or 3) worsened in severity during treatment relative to the state before treatment, when continuous.

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib TEAEs	4 Participants	3 Participants	4 Participants	6 Participants	1 Participants	2 Participants	4 Participants	4 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Treatment-related TEAEs	1 Participants	3 Participants	4 Participants	6 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Severe TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Treatment Period 1, Day 1 (Visit 2); Treatment Period 2, Day 8 (Visit 8)

Population: The Palatability Analysis Set was the group of subjects who received at least 1 dose of study drug and completed the visual analog scale (VAS) in at least one treatment period.

A hedonic Visual Analog Scale (VAS) was used to assess taste likability or "palatability" between a) lenvatinib suspension formulated with water versus the capsule formulation, b) a lenvatinib suspension formulated with with apple juice versus one formulated with water, and c) a lenvatinib suspension formulated with water administered 23 hours versus 2 hours after preparation. All participants selected one face based on flavor, smell, sweetness, acidity, saltiness, bitterness, and texture or mouth feel for each formulation they consumed. Each face had an associated score (1: Very Bad (angry face), 2: Bad (sad face), 3: Maybe Good or Maybe Bad (neutral face), 4: Good (smiling face), 5: Very Good (laughing face)). The VAS hedonic scale scores were summarized using descriptive statistics separately for each arm by formulation (Arm 1), number of capsules (2 vs 5 capsules) and preparation type (water vs apple juice) (Arm 2), and time of administration relative to preparation (Arm 3).

Outcome measures

Outcome measures
Measure	Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 Participants On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 Participants On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 Participants On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Summary Scores for Palatability of Lenvatinib Flavor Score	4.0 Score on a scale Interval 1.0 to 5.0	2.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	4.0 Score on a scale Interval 2.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	4.0 Score on a scale Interval 2.0 to 5.0	2.5 Score on a scale Interval 1.0 to 4.0	2.0 Score on a scale Interval 1.0 to 4.0
Summary Scores for Palatability of Lenvatinib Smell Score	4.0 Score on a scale Interval 3.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	4.0 Score on a scale Interval 3.0 to 5.0	4.0 Score on a scale Interval 2.0 to 5.0	3.5 Score on a scale Interval 2.0 to 5.0	4.0 Score on a scale Interval 3.0 to 4.0	4.0 Score on a scale Interval 3.0 to 5.0	3.0 Score on a scale Interval 2.0 to 5.0
Summary Scores for Palatability of Lenvatinib Sweetness Score	4.0 Score on a scale Interval 2.0 to 5.0	2.0 Score on a scale Interval 1.0 to 4.0	3.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 4.0	4.0 Score on a scale Interval 2.0 to 5.0	2.0 Score on a scale Interval 1.0 to 4.0	2.0 Score on a scale Interval 1.0 to 4.0
Summary Scores for Palatability of Lenvatinib Acidity Score	4.0 Score on a scale Interval 2.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	4.0 Score on a scale Interval 2.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 2.0 to 4.0	2.5 Score on a scale Interval 1.0 to 4.0	3.0 Score on a scale Interval 1.0 to 4.0
Summary Scores for Palatability of Lenvatinib Saltiness Score	4.0 Score on a scale Interval 2.0 to 5.0	3.0 Score on a scale Interval 2.0 to 5.0	3.0 Score on a scale Interval 2.0 to 5.0	4.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 4.0	4.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 2.0 to 5.0	4.0 Score on a scale Interval 1.0 to 5.0
Summary Scores for Palatability of Lenvatinib Bitterness Score	3.5 Score on a scale Interval 2.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	3.5 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 2.0 to 4.0	3.0 Score on a scale Interval 1.0 to 5.0	2.0 Score on a scale Interval 1.0 to 5.0
Summary Scores for Palatability of Lenvatinib Texture or Mouth feel Score	4.0 Score on a scale Interval 2.0 to 5.0	2.0 Score on a scale Interval 1.0 to 4.0	3.0 Score on a scale Interval 1.0 to 5.0	3.5 Score on a scale Interval 2.0 to 5.0	2.0 Score on a scale Interval 1.0 to 4.0	4.0 Score on a scale Interval 1.0 to 5.0	3.0 Score on a scale Interval 1.0 to 5.0	2.0 Score on a scale Interval 1.0 to 5.0

Adverse Events

Arm 1: 11 mg Lenvatinib Suspension in Water

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 1: 11 mg Lenvatinib Capsule With Water

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1: 11 mg Lenvatinib Suspension in Water n=19 participants at risk On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (11 mg) suspension in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 1: 11 mg Lenvatinib Capsule With Water n=20 participants at risk On the administered lenvatinib (11 mg) capsules with 240 mL (8 fluid ounces) of water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) n=10 participants at risk On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) n=9 participants at risk On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 5 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) n=10 participants at risk On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in water. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice) n=10 participants at risk On the mornings of Days 1 and 8 following an overnight fast of at least 10 hours, participants were administered a suspension of 2 capsules of lenvatinib (11 mg total) in apple juice. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) n=18 participants at risk On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 23 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.	Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) n=19 participants at risk On the mornings of Days 1 and 8, following an overnight fast of at least 10 hours, participants were administered lenvatinib (23 mg) suspension in water, which had been prepared 2 hours prior to administration. No food was allowed for at least 4 hours post dose. Water was allowed ad libitum except for the period beginning 1 hour before and until 1 hour after lenvatinib administration. Treatments were administered at the same time on the 2 dosing days. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
Gastrointestinal disorders Diarrhoea	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Gastrointestinal disorders Flatulence	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
General disorders Asthenia	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
General disorders Chills	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
General disorders Fatigue	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
General disorders Feeling hot	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Blood bilirubin abnormal	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Nervous system disorders Headache	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	11.1% 1/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	11.1% 2/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Nervous system disorders Hypoaesthesia	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Psychiatric disorders Euphoric mood	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.6% 1/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.0% 1/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Blood glucose decreased	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Blood phosphorus decreased	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Blood pressure increased	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Heart rate decreased	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	11.1% 1/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Urine analysis abnormal	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Skin and subcutaneous tissue disorders Erythema	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	10.0% 1/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Gastrointestinal disorders Abdominal pain	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Gastrointestinal disorders Nausea	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.6% 1/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Gastrointestinal disorders Vomiting	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.6% 1/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
General disorders Pain	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.6% 1/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Blood lactate dehydrogenase increased	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.6% 1/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Blood triglycerides increased	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations Liver function test abnormal	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.6% 1/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Investigations White blood cell count decreased	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Psychiatric disorders Insomnia	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.6% 1/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/20 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/9 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/10 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	0.00% 0/18 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment	5.3% 1/19 • From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment

Additional Information

Eisai Medical Research Inc.

Eisai Inc.

Phone: 1-888-422-4743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER