Clinical trial NCT06533475: A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
Official title: An Open-Label, Randomized Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of Minzasolmin and the Potential Effect of Food on the Pharmacokinetics of Minzasolmin in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: minzasolmin
Phase 1
Healthy Participants
Bioavailability
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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 \<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

Primary outcomes:
measure: Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fasted conditions
timeFrame: 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.
measure: Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsules under fasted conditions
timeFrame: 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.
measure: Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fed conditions
timeFrame: 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.
measure: Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fasted conditions
timeFrame: 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.
measure: Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsules under fasted conditions
timeFrame: 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.
measure: Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fed conditions
timeFrame: 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.
measure: Maximum plasma concentration (Cmax) of minzasolmin tablets under fasted conditions
timeFrame: 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.
measure: Maximum plasma concentration (Cmax) of minzasolmin granules in capsules under fasted conditions
timeFrame: 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.
measure: Maximum plasma concentration (Cmax) of minzasolmin tablets under fed conditions
timeFrame: 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.
Secondary outcomes:
measure: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: From Baseline to Safety Follow-Up (up to 48 days)
measure: Occurrence of serious treatment-emergent adverse events (serious TEAEs)
timeFrame: From Baseline to Safety Follow-Up (up to 48 days)
measure: Occurrence of TEAEs leading to withdrawal from study
timeFrame: From Baseline to Safety Follow-Up (up to 48 days)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Up0152 1001
Study officials:
References: