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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511301-31-00 | Registry Identifier | EU CT number | |
| U1111-1306-5483 | Other Identifier | UTN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Treatment C-A-B | 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. C: Tablet formulation (fed); A: Granules in capsule (fasting); B: Tablet formulation (fasting). |
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| Treatment A-C-B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minzasolmin tablet formulation under fasting condition | Drug | Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0152 1001 | Berlin | Germany |
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.
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The Participant Flow refers to the Randomized Set.
The study started to enroll participants in September 2024 and concluded in November 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment ABC | Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2024 | Nov 11, 2025 |
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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); C: Tablet formulation (fed); B: Tablet formulation (fasting).
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| Treatment B-A-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. B: Tablet formulation (fasting); A: Granules in capsule (fasting); C: Tablet formulation (fed). |
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| Treatment C-B-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. C: Tablet formulation (fed); B: Tablet formulation (fasting); A: Granules in capsule (fasting). |
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| Minzasolmin Granules in capsule under fasting condition | Drug | Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition |
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| Minzasolmin tablet formulation under fed condition | Drug | Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition |
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| 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:
| 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. | From Baseline to end of Safety Follow-Up, up to 48 days |
| FG001 | Treatment BCA | Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| FG002 | Treatment CAB | Participants received a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 1 followed by minzasolmin granules in capsules administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| FG003 | Treatment ACB | Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| FG004 | Treatment BAC | Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| FG005 | Treatment CBA | Participants received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1 followed by a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 2, further followed by minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
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Baseline Characteristics refer to the SS which consisted of all study participants who were randomized and received full or partial study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment ABC | Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| BG001 | Treatment BCA | Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| BG002 | Treatment CAB | Participants received a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 1 followed by minzasolmin granules in capsules administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| BG003 | Treatment ACB | Participants received minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 1 followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 2, further followed by a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| BG004 | Treatment BAC | Participants received a single dose of minzasolmin tablet under fasting conditions (Treatment B) in Period 1 followed by minzasolmin granules in capsules, administered under fasting conditions (Treatment A) in Period 2, further followed by a single dose of minzasolmin tablet under fed conditions (Treatment C) in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| BG005 | Treatment CBA | Participants received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1 followed by a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 2, further followed by minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 3. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Pharmacokinetics (PK) Set consisted of all study participants in the safety set (SS) who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanograms per milliliter (h*ng/mL) | 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 |
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| Primary | 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. | The PK set consisted of all study participants in the SS who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
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| Primary | Maximum Plasma Concentration (Cmax) of Minzasolmin | Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of Minzasolmin. | PK set consisted of all study participants in the SS who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per mililiter (ng/mL) | 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 |
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| Secondary | 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. | The SS consisted of all study participants who were randomized and received full or partial study medication. Study participants were classified according to the treatment that participants actually received. | Posted | Number | percentage of participants | From Baseline to end of Safety Follow-Up, up to 48 days |
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| Secondary | 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:
| The SS consisted of all study participants who were randomized and received full or partial study medication. Study participants were classified according to the treatment that participants actually received. | Posted | Number | percentage of participants | From Baseline to end of Safety Follow-Up, up to 48 days |
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| Secondary | 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. | The SS consisted of all study participants who were randomized and received full or partial study medication. Study participants were classified according to the treatment that participants actually received. | Posted | Number | percentage of participants | From Baseline to end of Safety Follow-Up, up to 48 days |
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From Baseline to end of Safety Follow-Up, up to 48 days
A TEAE was defined 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Minzasolmin Capsule (Fasted) | All participants who received minzasolmin granules in capsules (Treatment A), administered under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period. | 0 | 18 | 0 | 18 | 3 | 18 |
| EG001 | Minzasolmin Tablet (Fasted) | All participants who received a single dose of minzasolmin tablet (Treatment B) under fasting conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period. | 0 | 18 | 0 | 18 | 4 | 18 |
| EG002 | Minzasolmin Tablet (Fed) | All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period. | 0 | 18 | 0 | 18 | 4 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Allergy to arthropod bite | Immune system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2024 | Nov 11, 2025 | SAP_001.pdf |
| 65 - <85 years |
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| >=85 years |
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| Male |
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| Not Hispanic or Latino |
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| GLSM Ratio |
| 1.075 |
| 2-Sided |
| 90 |
| 1.024 |
| 1.130 |
The GLSM ratio was calculated as: Minzasolmin Tablet (Fed)/Minzasolmin Tablet (Fasted). |
| Other |
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| OG002 | Minzasolmin Tablet (Fed) | All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period. |
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| OG002 | Minzasolmin Tablet (Fed) | All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions on Day 1 in Period 1, Day 6 in Period 2 and Day 11 in Period 11. Each treatment period was of 1 Day (Days 1, 6, and 11 respectively) only, separated by 4-Days Washout period. |
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| OG002 | MinzasolminTablet (Fed) | All participants who received a single dose of minzasolmin tablet (Treatment C) under fed conditions in Period 1, 2 and 3. Each treatment period was of 1 Day (Day 1, 6 and 11 respectively) only, separated by 4-Days Washout period. |
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