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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523254-14-00 | EU Trial (CTIS) Number | ||
| AXL-5006-101 | Other Identifier | Vertero Therapeutics |
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This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C).
Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights.
Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit.
Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.
Part A will consist of five single ascending dose (SAD) cohorts, with 8 participants in each cohort. Participants will be randomized to receive either VT-5006 or placebo in a 6:2 ratio. One cohort of 8 participants will complete an additional clinic stay for the purpose of evaluating food effect (FE).
Part B will consist of two multiple ascending dose (MAD) cohorts, with 10 participants in each cohort. Participants will be randomized to receive either VT-5006 or placebo in an 8:2 ratio.
Part C will consist of a single cohort of approximately 24 (or up to 32) participants with PD, randomized to receive either VT-5006 (high dose), VT-5006 (low dose) or placebo over 28 days in a 9:9:6 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A SAD Active | Experimental | Single Ascending Doses of VT-5006 |
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| Part A SAD Placebo | Placebo Comparator | Matched Placebo |
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| Part B MAD Active | Experimental | Multiple ascending doses of VT-5006 |
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| Part B MAD Placebo | Placebo Comparator | Matched Placebo |
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| Part C Active Low Dose | Experimental | Low dose VT-5006 |
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| Part C Active High Dose | Experimental | High dose VT-5006 |
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| Part C Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT-5006 | Drug | Oral Capsules, Active |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events (AEs) | Incidence of treatment-emergent AEs (e.g. clinically significant electrocardiogram, vital signs and physical examination abnormalities; clinically significant changes on the Columbia-Suicide Severity Rating Scale [C-SSRS]). | Part A: Up to 8 days; Part B: Up to 15 days; Part C: Up to 35 days; |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic (PK) parameter: Cmax | Maximum peak plasma concentration (Cmax) | Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28 |
| Plasma PK parameter: Tmax |
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Parts A and B enroll healthy volunteers; only key entry criteria for Part C are described below.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| P.H.C. Kremer | Contact | +31 0715246400 | clintrials@chdr.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Human Drug Research | Recruiting | Leiden | Netherlands |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo Comparator |
Matched placebo |
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| Placebo | Drug | Oral Capsules, Matched Placebo |
|
Time to Maximum Observed Concentration (Tmax) |
| Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28 |
| Plasma PK parameter: AUClast | Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) | Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28 |
| Plasma PK parameters: AUCinf | Area under the concentration-time curve extrapolated to infinity (AUCinf) | Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28 |
| Plasma PK parameter: t1/2 | Terminal-phase elimination half-life (t1/2) | Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28 |
| Plasma PK parameter: Apparent CL/F | Apparent clearance (CL/F) | Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28 |
| Plasma PK parameter: Apparent Vd/F | Apparent volume of distribution (Vd/F) | Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28 |
| Food effect on plasma PK: Cmax | Cmax following a high fat meal | Part A: predose and up to 72 hours postdose |
| Food effect on plasma PK: Tmax | Tmax following a high fat meal | Part A: predose and up to 72 hours postdose |
| Food effect on plasma PK: AUC | AUC following a high fat meal | Part A: predose and up to 72 hours postdose |
| Urine PK parameter: CLr | Renal clearance rate (CLr) | Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28 |
| Urine PK parameter: Cumulative amount excreted (urine) | Cumulative amount excreted in urine | Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28 |
| Urine PK parameter: %Cumulative amount excreted | Percent cumulative amount excreted in urine | Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28 |
| Feces PK parameter: Observed concentration | Observed concentration in fecal samples (ng/mL) | Part A: 0-72 hours postdose; Part B: 0-12 hours and 12-24 hours postdose on Days 1 and 7, and anytime postdose on Day 4; Part C: Anytime postdose on Days 8, 15, 22 and 28 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |