Up0152 1001
Berlin, Germany
NCT Number: NCT06533475
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Berlin, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In addition, any study participant with any of the following findings will be excluded at Screening:
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition
Other names: UCB0599
Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition
Other names: UCB0599
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition
Other names: UCB0599
Time frame: 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
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.
Time frame: 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
AUC was defined as the area under the plasma concentration-time curve from time zero to infinity for Minzasolmin.
Time frame: 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
Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of Minzasolmin.
Time frame: From Baseline to end of Safety Follow-Up, up to 48 days
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
Time frame: From Baseline to end of Safety Follow-Up, up to 48 days
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed:
Time frame: From Baseline to end of Safety Follow-Up, up to 48 days
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. Percentage of participants with TEAEs leading to withdrawal from study were reported.
UCB Biopharma SRL
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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