A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
- Conditions
- Healthy Participants
- Interventions
- Drug: Minzasolmin tablet formulation under fasting conditionDrug: Minzasolmin Granules in capsule under fasting conditionDrug: Minzasolmin tablet formulation under fed condition
- Registration Number
- NCT06533475
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C-A-B Minzasolmin tablet formulation under fasting condition 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). Treatment B-C-A Minzasolmin Granules in capsule under fasting condition 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). Treatment A-B-C Minzasolmin tablet formulation under fasting condition 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). Treatment A-B-C Minzasolmin tablet formulation under fed condition 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). Treatment B-C-A Minzasolmin tablet formulation under fed condition 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). Treatment C-A-B Minzasolmin tablet formulation under fed condition 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). Treatment A-C-B Minzasolmin Granules in capsule under fasting condition 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). Treatment B-A-C Minzasolmin tablet formulation under fasting condition 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). Treatment C-B-A Minzasolmin Granules in capsule under fasting condition 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). Treatment B-C-A Minzasolmin tablet formulation under fasting condition 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). Treatment C-A-B Minzasolmin Granules in capsule under fasting condition 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). Treatment A-B-C Minzasolmin Granules in capsule under fasting condition 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). Treatment A-C-B Minzasolmin tablet formulation under fed condition 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). Treatment A-C-B Minzasolmin tablet formulation under fasting condition 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). Treatment B-A-C Minzasolmin Granules in capsule under fasting condition 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). Treatment B-A-C Minzasolmin tablet formulation under fed condition 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). Treatment C-B-A Minzasolmin tablet formulation under fasting condition 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). Treatment C-B-A Minzasolmin tablet formulation under fed condition 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).
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fasted conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. AUC0-t: Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablet formulation under fasted conditions.
Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsules under fasted conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. AUC0-t: Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsule formulation under fasted conditions.
Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fed conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. AUC0-t: Area under the plasma concentration-time curve from time 0 to t for minzasolmin tablet formulation under fed conditions.
Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fasted conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. AUC: Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablet formulation under fasted conditions.
Maximum plasma concentration (Cmax) of minzasolmin granules in capsules under fasted conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. Cmax: Maximum plasma concentration of minzasolmin granules in capsule formulation under fasted conditions.
Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fed conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. AUC: Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablet formulation under fed conditions.
Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsules under fasted conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. AUC: Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsule formulation under fasted conditions.
Maximum plasma concentration (Cmax) of minzasolmin tablets under fasted conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. Cmax: Maximum plasma concentration of minzasolmin tablet formulation under fasted conditions.
Maximum plasma concentration (Cmax) of minzasolmin tablets under fed conditions Sampling timepoints will be: predose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after minzasolmin administration on Day 1, Day 6, and Day 11. Cmax: Maximum plasma concentration of minzasolmin tablet formulation under fed conditions.
- Secondary Outcome Measures
Name Time Method Occurrence of treatment-emergent adverse events (TEAEs) From Baseline to Safety Follow-Up (up to 48 days) An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency
Occurrence of serious treatment-emergent adverse events (serious TEAEs) From Baseline to Safety Follow-Up (up to 48 days) A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose:
Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical eventsOccurrence of TEAEs leading to withdrawal from study From Baseline to Safety Follow-Up (up to 48 days) Occurrence of TEAE leading to withdrawal is defined as any untoward medical occurrence of adverse events do not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency and conclude with withdrawal of study participants from study.
Trial Locations
- Locations (1)
Up0152 1001
🇩🇪Berlin, Germany