A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
NCT Number: NCT06533475
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: Minzasolmin tablet formulation under fasting condition|DRUG: Minzasolmin Granules in capsule under fasting condition|DRUG: Minzasolmin tablet formulation under fed condition
Sponsor: UCB Biopharma SRL
Sex: ALL
Age: ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-26
Completion Date: 2024-10-09

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.

Primary Outcome Measures: Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fasted conditions, AUC0-t: Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablet formulation under fasted conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsules under fasted conditions, AUC0-t: Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsule formulation under fasted conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fed conditions, AUC0-t: Area under the plasma concentration-time curve from time 0 to t for minzasolmin tablet formulation under fed conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fasted conditions, AUC: Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablet formulation under fasted conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsules under fasted conditions, AUC: Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsule formulation under fasted conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fed conditions, AUC: Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablet formulation under fed conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Maximum plasma concentration (Cmax) of minzasolmin tablets under fasted conditions, Cmax: Maximum plasma concentration of minzasolmin tablet formulation under fasted conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Maximum plasma concentration (Cmax) of minzasolmin granules in capsules under fasted conditions, Cmax: Maximum plasma concentration of minzasolmin granules in capsule formulation under fasted conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.|Maximum plasma concentration (Cmax) of minzasolmin tablets under fed conditions, Cmax: Maximum plasma concentration of minzasolmin tablet formulation under fed conditions., Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11.
Secondary Outcome Measures: Occurrence of treatment-emergent adverse events (TEAEs), An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency, From Baseline to Safety Follow-Up (up to 48 days)|Occurrence of serious treatment-emergent adverse events (serious TEAEs), A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose:

Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical events, From Baseline to Safety Follow-Up (up to 48 days)|Occurrence of TEAEs leading to withdrawal from study, Occurrence of TEAE leading to withdrawal is defined as any untoward medical occurrence of adverse events do not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency and conclude with withdrawal of study participants from study., From Baseline to Safety Follow-Up (up to 48 days)