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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition
Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition
Up0152 1001
Berlin, Germany
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.
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
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.
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
Maximum Plasma Concentration (Cmax) of Minzasolmin
Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of 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
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Important medical events such as (but not limited to) invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, convulsions not resulting in hospitalization, or development of intervention dependency or intervention abuse.
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Time frame: From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With TEAEs Leading to Withdrawal From Study
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.
Time frame: From Baseline to end of Safety Follow-Up, up to 48 days