NCT05195892

Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

A Single-center, Randomized, Open-label, Three-period Crossover Study to Investigate the Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation, and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess bioequivalence of the granule formulation of alpelisib as compared to the film-coated tablet formulation in healthy volunteers in the fed state. In addition, the food effect of the granule formulation will be investigated between the fed state and the fasted state.

Detailed description

This is a single-center, randomized, open-label, three-period six-sequence crossover study. The study consists of a screening period followed by Periods 1, 2, and 3 and a safety follow-up. Randomization occurs at the beginning of Period 1, whereby every participant who passes the screening will be randomized to one of 6 sequences with 1:1:1:1:1:1 randomization ratio. Each sequence consists of a permutation of three treatments: A, B and C. The order of the sequence of the treatments (A, B, C) will be determined by randomization to the assigned sequence. A total of 60 participants will be enrolled with approximately 10 participants per sequence, in order to obtain at least 48 evaluable participants for comparison of the granule formulation in fed status and the film-coated tablet formulation in fed status.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Treatment A	Single oral dose of alpelisib film-coated tablet at 50 mg in fed state
DRUG	Treatment B	Single oral dose of alpelisib granule at 50 mg in fed state
DRUG	Treatment C	Single oral dose of alpelisib granule at 50 mg in fasted state

Timeline

• Start date: 2022-02-03
• Primary completion: 2022-11-09
• Completion: 2022-11-09
• First posted: 2022-01-19
• Last updated: 2022-12-28

Locations

1 site across 1 country: United Kingdom