Healthy volunteers help Fine-Tune minzasolmin tablet absorption
NCT ID NCT06533475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study involved 18 healthy adults to see how a new tablet version of the drug minzasolmin is absorbed compared to an older capsule form, and whether food changes absorption. Participants took single doses under fasting or fed conditions. The study is complete and focused on drug levels in the blood, not on treating any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Minzasolmin (UCB0599)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
-
Nov 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Up0152 1001
Berlin, Germany
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