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The study will be conducted in adult healthy participants and will consist of two phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a Screening Period and a Baseline Period. The Randomization Phase will consist of 2 Periods (each 6 days long) separated by a 1-day long Baseline Period and End of Treatment (EOT) Period. A total of 60 participants will be enrolled into one of three arms. Arms 1 and 3 consist of 2 sequences, and Arm 2 consists of 4 sequences (as this is an incomplete block design with 2 factors [number of capsules and whether water or apple juice is used as vehicle]). Each participant will be randomized into one of 8 sequences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib 11 mg (suspension formulation) | Experimental | Arm 1 will have 2 sequences:
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| Lenvatinib 11 mg (2 vs 5 capsules) | Experimental | Arm 2 will have 4 sequences:
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| Lenvatinib 23 mg | Experimental | Arm 3 will have 2 sequences:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | All participants will receive one single dose in each of the 2 treatment periods (total of 2 doses). The total duration of the treatment periods is 12 days (6 days per period) in healthy adult volunteers. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t)) | 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). | 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) |
| Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC(0-inf)) | 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. | 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) |
| Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24)) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary Scores for Palatability of Lenvatinib | 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). |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Las Vegas | Nevada | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 1: Predose up to 24 hours post dose |
| Area Under the Plasma Concentration-Time Curve From Zero to 72 Hours (AUC(0-72)) | 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. | Treatment Period 1: Predose up to 72 hours postdose |
| Apparent Clearance (CL/F) | 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. | 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) |
| Apparent Volume of Distribution (Vz/F) | 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). | 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) |
| Maximum Concentration (Cmax) of Lenvatinib in Plasma | 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). | 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) |
| Time Prior to the First Measureable Concentration of Lenvatinib (Tlag) | 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. | 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) |
| Time to Maximum Plasma Concentration (Tmax) | 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. | 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) |
| Terminal Elimination Phase Half-life (t1/2) | 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. | 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) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib | 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. | From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days |
| Treatment Period 1, Day 1 (Visit 2); Treatment Period 2, Day 8 (Visit 8) |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
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| Treatment Period 2 |
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Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: 11 mg Lenvatinib Suspension in Water | 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. |
| BG001 | Arm 1: 11 mg Lenvatinib Capsule With Water | 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. |
| BG002 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) | 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. |
| BG003 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) | 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. |
| BG004 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) | 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. |
| BG005 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice) | 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. |
| BG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| BG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t)) | 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). | 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. | Posted | Mean | Standard Deviation | hr·ng/mL | 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) |
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| Primary | Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC(0-inf)) | 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. | PK analysis set | Posted | Mean | Standard Deviation | hr·ng/mL | 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) |
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| Primary | Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24)) | 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. | PK analysis set | Posted | Mean | Standard Deviation | h·ng/mL | Treatment Period 1: Predose up to 24 hours post dose |
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| Primary | Area Under the Plasma Concentration-Time Curve From Zero to 72 Hours (AUC(0-72)) | 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. | PK analysis set | Posted | Mean | Standard Deviation | hr·ng/mL | Treatment Period 1: Predose up to 72 hours postdose |
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| Primary | Apparent Clearance (CL/F) | 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. | PK analysis set | Posted | Mean | Standard Deviation | L/hour | 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) |
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| Primary | Apparent Volume of Distribution (Vz/F) | 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). | PK analysis set | Posted | Mean | Standard Deviation | Liters | 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) |
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| Primary | Maximum Concentration (Cmax) of Lenvatinib in Plasma | 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). | Pharmacokinetic (PK) analysis set | Posted | Mean | Standard Deviation | ng/mL | 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) |
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| Primary | Time Prior to the First Measureable Concentration of Lenvatinib (Tlag) | 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. | PK analysis set | Posted | Median | Full Range | Hours | 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) |
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| Primary | Time to Maximum Plasma Concentration (Tmax) | 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. | PK analysis set | Posted | Median | Full Range | Hours | 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) |
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| Primary | Terminal Elimination Phase Half-life (t1/2) | 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. | PK analysis set | Posted | Mean | Standard Deviation | Hours | 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) |
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| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib | 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. | 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 | Posted | Number | Participants | From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days |
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| Secondary | Summary Scores for Palatability of Lenvatinib | 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). | 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. | Posted | Median | Full Range | Score on a scale | Treatment Period 1, Day 1 (Visit 2); Treatment Period 2, Day 8 (Visit 8) |
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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
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: 11 mg Lenvatinib Suspension in Water | 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. | 0 | 19 | 0 | 19 | 4 | 19 |
| EG001 | Arm 1: 11 mg Lenvatinib Capsule With Water | 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. | 0 | 20 | 0 | 20 | 6 | 20 |
| EG002 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) | 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. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG003 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) | 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. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG004 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) | 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. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG005 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice) | 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. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. | 0 | 18 | 0 | 18 | 3 | 18 |
| EG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. | 0 | 19 | 0 | 19 | 4 | 19 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Blood bilirubin abnormal | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Heart rate decreased | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Urine analysis abnormal | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA VERSION 17.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA VERSION 17.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Research Inc. | Eisai Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
| ID | Term |
|---|---|
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
| Adverse Event |
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| Use of proscribed medications |
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| Female |
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| OG004 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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.
| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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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.
| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | Arm 2 group description: 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 11 mg Lenvatinib Suspension in Water (2 Hours) | 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, 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. |
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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. |
| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG002 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG002 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG001 | Arm 1: 11 mg Lenvatinib Capsule With Water | 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. |
| OG002 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: 11 mg Lenvatinib (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: 11 mg Lenvatinib (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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| OG001 | Arm 1: 11 mg Lenvatinib Capsule With Water | 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. |
| OG002 | Lenvatinib 11 mg (Suspension of 5 Capsules in Water) | 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. |
| OG003 | Arm 2: Lenvatinib 11 mg (Suspension of 5 Capsules in Juice) | 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. |
| OG004 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Water) | 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. |
| OG005 | Arm 2: Lenvatinib 11 mg (Suspension of 2 Capsules in Juice) | 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. |
| OG006 | Arm 3: 23 mg Lenvatinib Suspension in Water (23 Hours) | 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. |
| OG007 | Arm 3: 23 mg Lenvatinib Suspension in Water (2 Hours) | 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. |
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