Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Participants

Keywords

minzasolminPhase 1Healthy ParticipantsBioavailability

Outcome Measures

Primary Outcomes (3)

Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to the last measurable drug concentration sampling time for Minzasolmin.
Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11
Area Under the Plasma Concentration-time Curve From Zero to Infinity for Minzasolmin
AUC was defined as the area under the plasma concentration-time curve from time zero to infinity for Minzasolmin.
Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11
Maximum Plasma Concentration (Cmax) of Minzasolmin
Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of Minzasolmin.
Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11

Secondary Outcomes (3)

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs)
From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With TEAEs Leading to Withdrawal From Study
From Baseline to end of Safety Follow-Up, up to 48 days

Study Arms (6)

Treatment A-B-C

EXPERIMENTAL

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).

Drug: Minzasolmin tablet formulation under fasting conditionDrug: Minzasolmin Granules in capsule under fasting conditionDrug: Minzasolmin tablet formulation under fed condition

Treatment B-C-A

EXPERIMENTAL

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).

Drug: Minzasolmin tablet formulation under fasting condition

Interventions

Minzasolmin tablet formulation under fasting conditionDrug

Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition

Also known as: UCB0599

Treatment A-B-CTreatment A-C-BTreatment B-A-CTreatment B-C-ATreatment C-A-BTreatment C-B-A

Minzasolmin Granules in capsule under fasting condition

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Minzasolmin
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
UCB0599 PRD4385815
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Minzasolmin
Named ingredient: Minzasolmin
View registry record
UCB0599 PRD4385815
Named ingredient: Minzasolmin
View registry record

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify 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

Sponsors & Collaborators

UCB Biopharma
Industrylead
UCB Biopharma SRL
Industrylead

Study Sites (1)

Up0152 1001

Berlin, Germany

Results Point of Contact

Title: UCB
Organization: Cares

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

September 6, 2024

Actual (reported)

Primary Completion

You may not qualify 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
\- 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

A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (6)

Treatment A-B-C

Treatment B-C-A

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

Treatment C-A-B

Treatment A-C-B

Treatment B-A-C

Treatment C-B-A

You may not qualify if:

Data Sharing

Source records

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (6)

Treatment A-B-C

Treatment B-C-A

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

Treatment C-A-B

Treatment A-C-B

Treatment B-A-C

Treatment C-B-A

You may not qualify if:

Data Sharing

Source records

Documents

Locations