A study to learn how much minzasolmin gets into the body when taken in different ways and how safe it is in healthy adults

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UCB Biopharma

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

6 Sep 2024 → 17 Nov 2024

Decision date (initial)

2024-09-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511301-31-00

WHO UTN

U1111-1306-5483

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Safety

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.

Secondary objectives 1

1. To evaluate the safety and tolerability of single-dose administration of minzasolmin in healthy participants using different formulations in fed condition (tablet formulation) and fasting condition (tablet and ‘granules in capsule’ formulation).

Conditions and MedDRA coding

Healthy Participants

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002866-PIP01-20

Plan to share IPD

No

IPD plan description

Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. - Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
2. - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
3. - 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 8

1. -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
2. -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
3. -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)
4. -Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)
5. -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
6. -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
7. -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
8. -Participant has donated blood or experienced blood loss >350mL within the last 1 month before the first IMP administration

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 9

1. Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fasted conditions
2. Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsules under fasted conditions
3. Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fed conditions
4. Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fasted conditions
5. Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsules under fasted conditions
6. Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fed conditions
7. Maximum plasma concentration (Cmax) of minzasolmin tablets under fasted conditions
8. Maximum plasma concentration (Cmax) of minzasolmin granules in capsules under fasted conditions
9. Maximum plasma concentration (Cmax) of minzasolmin tablets under fed conditions

Secondary endpoints 3

1. Occurrence of treatment-emergent adverse events (TEAEs)
2. Occurrence of serious treatment-emergent adverse events (serious TEAEs)
3. Occurrence of TEAEs leading to withdrawal from study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation

UCB Biopharma

Address

Researchdreef 60

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Public contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Third parties 6

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications