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

NCT06533475 | Completed Phase 1 Results

• 3 other identifiers: UP01522024-511301-31-00U1111-1306-5483
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

minzasolmin; Phase 1; Healthy Participants; Bioavailability

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

  From Baseline to end of Safety Follow-Up, up to 48 days

• Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs)

  From Baseline to end of Safety Follow-Up, up to 48 days

• Percentage of Participants With TEAEs Leading to Withdrawal From Study

  From Baseline to end of Safety Follow-Up, up to 48 days

Study Arms (6)

Treatment A-B-C

EXPERIMENTAL

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 Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

Treatment B-C-A

EXPERIMENTAL

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 Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

Treatment C-A-B

EXPERIMENTAL

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 Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

Treatment A-C-B

EXPERIMENTAL

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 Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

Treatment B-A-C

EXPERIMENTAL

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 Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

Treatment C-B-A

EXPERIMENTAL

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 Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

Interventions

Minzasolmin tablet formulation under fasting condition DRUG

Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition

Also known as: UCB0599

Treatment A-B-C; Treatment A-C-B; Treatment B-A-C; Treatment B-C-A; Treatment C-A-B; Treatment C-B-A

Minzasolmin Granules in capsule under fasting condition DRUG

Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition

Also known as: UCB0599

Treatment A-B-C; Treatment A-C-B; Treatment B-A-C; Treatment B-C-A; Treatment C-A-B; Treatment C-B-A

Minzasolmin tablet formulation under fed condition DRUG

Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition

Also known as: UCB0599

Treatment A-B-C; Treatment A-C-B; Treatment B-A-C; Treatment B-C-A; Treatment C-A-B; Treatment C-B-A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Up0152 1001

Berlin, Germany

Location

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: September 6, 2024
• Primary Completion: November 17, 2024
• Study Completion: November 17, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)