Conditions: Healthy Volunteers
Keywords: Bioequivalence Lenvatinib Healthy Volunteers Lenvima E7080
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 60
Healthy volunteers: yes

Brief summary:
This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.

Detailed description:
The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will have 2 periods: Screening and Baseline. The Randomization Phase will consist of three 6-day long Treatment Periods with each Treatment Period separated by a 1-day long Baseline. Sixty participants will be evenly randomized to 1 of 6 possible treatment sequences (A, B, C, D, E, or F). The 3 treatments vary by the level of crystalline polymorph Type-C present in the drug product batch used in each arm, respectively: Treatment 1 - low Type-C crystal level less than 12%; Treatment 2 - reference Type-C crystal level 12% to 26%; and Treatment 3 - high Type-C crystal level greater than 26%.

Arms:
arm 1: Participants will receive one dose of Treatment 1 followed by one dose of Treatment 2, then one dose of Treatment 3 arm 2: Participants will receive one dose of Treatment 2, followed by one dose of Treatment 3, then one dose of Treatment 1 arm 3: Participants will receive one dose of Treatment 3, followed by one dose of Treatment 1, then one dose of Treatment 2 arm 4: Participants will receive one dose of Treatment 3, followed by one dose of Treatment 2, then one dose of Treatment 1 arm 5: Participants will receive one dose of Treatment 1, followed by one dose of Treatment 3, then one dose of Treatment 2 arm 6: Participants will receive one dose of Treatment 2, followed by one dose of Treatment 1, then one dose of Treatment 3

Interventions: intervention 1: Lenvatinib 10 mg
Intervention descriptions: intervention 1: Treatment 1: low Type-C crystal level \<12%

Treatment 2: reference\* Type-C crystal level 12% to 26%

Treatment 3: high Type-C crystal level \>26%

Protocol document: