Conditions: Healthy Volunteers
Keywords: Bioavailability of Lenvatinib suspension Palatability of Lenvatinib suspension Lenvatinib Lenvima E7080 Capsule formulation Healthy volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 60
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: Arm 1 will have 2 sequences:

1. Sequence 1 - Treatment Period 1: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg); Treatment Period 2: 11 mg capsules (2 capsules, 1 x 10 mg and 1 x 1 mg)
2. Sequence 2 - Treatment Period 1: 11 mg capsules (2 capsules, 1 x 10 mg and 1 x 1 mg); Treatment Period 2: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg) arm 2: Arm 2 will have 4 sequences:

1. Sequence 3 - Treatment Period 1: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg) WATER; Treatment Period 2: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg) APPLE JUICE
2. Sequence 4 - Treatment Period 1: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg capsules) APPLE JUICE; Treatment Period 2: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg capsules) WATER
3. Sequence 5 - Treatment Period 1: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg capsules) WATER; Treatment Period 2: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg capsules) APPLE JUICE
4. Sequence 6 - Treatment Period 1: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg capsules) APPLE JUICE; Treatment Period 2: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg capsules) WATER arm 3: Arm 3 will have 2 sequences:

1. Sequence 7 - Treatment Period 1: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 23 hours after preparation; Treatment Period 2: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 2 hours after preparation
2. Sequence 8 - Treatment Period 1: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 2 hours after preparation; Treatment Period 2: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 23 hours after preparation

Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: 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.

Protocol document: