NCT06533475

A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants

An Open-Label, Randomized Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of Minzasolmin and the Potential Effect of Food on the Pharmacokinetics of Minzasolmin in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to estimate the relative bioavailability of a new minzasolmin tablet formulation versus reference 'granules in capsule' formulation in healthy participants and to evaluate the effect of food with the new tablet formulation on the pharmacokinetics (PK) of minzasolmin.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Minzasolmin tablet formulation under fasting condition	Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition
DRUG	Minzasolmin Granules in capsule under fasting condition	Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition
DRUG	Minzasolmin tablet formulation under fed condition	Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition

Timeline

• Start date: 2024-09-06
• Primary completion: 2024-11-17
• Completion: 2024-11-17
• First posted: 2024-08-01
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

1 site across 1 country: Germany