At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Lenvatinib 10 mgdrug
Likely dose
Lenvatinib 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Three-treatment, Three-period, Six-sequence Crossover, Single-center, Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Lenvatinib 10 mg for Healthy Volunteers. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
Primary CompletionAug 2013
First PostedMar 2016
TodayJul 2026
First PostedMar 30, 2016
Enrollment StartJul 1, 2013
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.3 years ago
Interventions
Lenvatinib 10 mgdrug
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%