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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Up0152 1001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• Body weight within 45 to 100kg (female) and 50 to 100kg (male) and body mass index (BMI) within the range 18 to 30kg/m2 (inclusive).

Exclusion Criteria:

• Participant has a history of chronic alcohol abuse (more than 24g [males] or 12g [females] per day; 12g pure alcohol are contained in approximately 300mL of beer (5%), 1 small glass [125 mL] of wine [12%], or 1 measure [40mL] of spirits [37.5%]) or drug abuse within the last 1 year from Screening, as defined according to the Diagnostic and Statistical Manual of Mental Disorders
• Study participant has received or intends to use any prescription or nonprescription medicines, including enzyme inhibitors or inducers, any gastric pH modifying agents, over the counter remedies, herbal and dietary supplements (including St. John's Wort) up to 2 weeks (4 weeks for enzyme inducers) or 5 half-lives of the respective drug (whichever is longer) before the first administration of minzasolmin
• Participant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 30 days or 5 half-lives, whichever is greatest, or is currently participating in another study of an IMP (and/or an investigational device)
• Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)
• Participant has total bilirubin >1.0xULN. Bilirubin >ULN and ≤1.5xULN is acceptable if fractioned and direct bilirubin <35%, and if a baseline diagnosis of Gilbert's syndrome is understood and recorded in ClinBase
• Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline, or a family history of sudden death due to long QT syndrome which, in the opinion of the investigator, would put the participant at increased risk of QT prolongation during the study

In addition, any study participant with any of the following findings will be excluded at Screening:

• QT interval corrected for heart rate using Fridericia's formula >450 msec for males and >470msec for females
• other conduction abnormalities (defined as pulse rate [PR] interval ≥220ms)

• irregular rhythm other than sinus arrhythmia or occasional, rare supraventricular, and rare ventricular ectopic beats

  - Study participant has a medical history or current diagnosis of renal impairment and/or Screening laboratory results show:

• An estimated glomerular filtration rate <90 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration formula)
• An albumin/creatinine ratio ≥30mg/mmol
• Urinary tract infection; in this case a study participant can be rescreened once the infection has been resolved - Participant has donated blood or experienced blood loss >350mL within the last 1 month before the first IMP administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A-B-C; Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. A: Granules in capsule (fasting); B: Tablet formulation (fasting); C: Tablet formulation (fed).	Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition; Other Names: UCB0599; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition; Other Names: UCB0599; Drug: Minzasolmin tablet formulation under fed condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition; Other Names: UCB0599
Experimental: Treatment B-C-A; Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. B: Tablet formulation (fasting); C: Tablet formulation (fed); A: Granules in capsule (fasting).	Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition; Other Names: UCB0599; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition; Other Names: UCB0599; Drug: Minzasolmin tablet formulation under fed condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition; Other Names: UCB0599
Experimental: Treatment C-A-B; Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. C: Tablet formulation (fed); A: Granules in capsule (fasting); B: Tablet formulation (fasting).	Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition; Other Names: UCB0599; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition; Other Names: UCB0599; Drug: Minzasolmin tablet formulation under fed condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition; Other Names: UCB0599
Experimental: Treatment A-C-B; Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. A: Granules in capsule (fasting); C: Tablet formulation (fed); B: Tablet formulation (fasting).	Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition; Other Names: UCB0599; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition; Other Names: UCB0599; Drug: Minzasolmin tablet formulation under fed condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition; Other Names: UCB0599
Experimental: Treatment B-A-C; Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. B: Tablet formulation (fasting); A: Granules in capsule (fasting); C: Tablet formulation (fed).	Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition; Other Names: UCB0599; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition; Other Names: UCB0599; Drug: Minzasolmin tablet formulation under fed condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition; Other Names: UCB0599
Experimental: Treatment C-B-A; Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. C: Tablet formulation (fed); B: Tablet formulation (fasting); A: Granules in capsule (fasting).	Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition; Other Names: UCB0599; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition; Other Names: UCB0599; Drug: Minzasolmin tablet formulation under fed condition; Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition; Other Names: UCB0599

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin	AUC0-t was defined as the area under the plasma concentration-time curve from time zero to the last measurable drug concentration sampling time for Minzasolmin.	Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11
Area Under the Plasma Concentration-time Curve From Zero to Infinity for Minzasolmin	AUC was defined as the area under the plasma concentration-time curve from time zero to infinity for Minzasolmin.	Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11
Maximum Plasma Concentration (Cmax) of Minzasolmin	Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of Minzasolmin.	Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.	From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs)	An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Important medical events such as (but not limited to) invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, convulsions not resulting in hospitalization, or development of intervention dependency or intervention abuse.	From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With TEAEs Leading to Withdrawal From Study	An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. Percentage of participants with TEAEs leading to withdrawal from study were reported.	From Baseline to end of Safety Follow-Up, up to 48 days

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Actual): November 17, 2024
• Study Completion (Actual): November 17, 2024

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Phase 1; Bioavailability; Healthy Participants; minzasolmin
• Other Study ID Numbers: UP0152; 2024-511301-31-00 (Registry Identifier: EU CT number); U1111-1306-5483 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No