Phase 1
N=18
A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT06533475 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin — 5612; 5710; 6140 hour*nanograms per milliliter (h*ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Minzasolmin tablet formulation under fasting condition (Drug); Minzasolmin Granules in capsule under fasting condition (Drug); Minzasolmin tablet formulation under fed condition (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin |
5612; 5710; 6140 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Zero to Infinity for Minzasolmin |
5656; 5769; 6190 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Minzasolmin |
627.2; 612.9; 622.5 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
16.7; 22.2; 22.2 | — |
| SECONDARY Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs) |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With TEAEs Leading to Withdrawal From Study |
0; 0; 0 | — |
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.
Eligibility Criteria
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 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 350mL within the last 1 month before the first IMP administration
Data sourced from ClinicalTrials.gov (NCT06533475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.