BridgeMD
A study to learn how much minzasolmin gets into the body when taken in different ways and how safe it is in healthy adults
EU CTIS ID: 2024-511301-31-00
What this study is testing
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 PK of minzasolmin.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 likely can't join 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
See the full eligibility criteria
Who can join
- - 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).
What rules you out
- -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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.