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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002402-21 | EudraCT Number |
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This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.
Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I (Panel 1): STR-324 or placebo | Experimental | Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization. |
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| Part I (Panel 2): STR-324 or placebo | Experimental | Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization. |
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| Part II (Panel 1): STR-324 or placebo | Experimental | Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization. |
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| Part II (Panel 2): STR-324 or placebo | Experimental | Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization. |
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| Part II (Panel 3): STR-324 or placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Short infusion of the solution for intravenous administration, Sodium Chloride 0.9% |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: number of subjects who experience (serious) treatment emergent adverse events, potential clinically changes in vital signs, ECG, holter, physical examinations, laboratory tests and urine production | Day 7 (+/- 2 days) post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Parts I and II: Maximum plasma concentration (Cmax) | Up to 24 hours for Part I and up to 52 hours for Part II | |
| Parts I and II:Time to maximum plasma concentration (Tmax) | Up to 24 hours for Part I and up to 52 hours for Part II |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHDR | Leiden | 2333 | Netherlands |
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For part I: crossover model For part II: parallel model
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Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization. |
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| STR-324 Dose Level 1 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level 2 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level 3 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level 4 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level 5 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level 6 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level 7 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level 8 | Drug | Short infusion of a solution for intravenous administration |
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| STR-324 Dose Level A | Drug | Long infusion of a solution for intravenous administration |
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| STR-324 Dose Level B | Drug | Long infusion of a solution for intravenous administration |
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| STR-324 Dose Level C | Drug | Long infusion of a solution for intravenous administration |
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| Placebo | Drug | Long infusion of the solution for intravenous administration, Sodium Chloride 0.9% |
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| Parts I and II: Area under the plasma concentration-time curve from zero to infinity(AUC0-inf) | Up to 24 hours for Part I and up to 52 hours for Part II |
| Parts I and II: Area under the plasma concentration-time curve from zero to the last measured concentration above the limit of quantification (AUC0-last) | Up to 24 hours for Part I and up to 52 hours for Part II |
| Parts I and II: Terminal disposition rate constant (λz) with the respective half-life (t½) | Up to 24 hours for Part I and up to 52 hours for Part II |
| Parts I and II: Amount excreted in urine in 24 hours | Up to 24 hours for Part I and up to 72 hours for Part II |
| Parts I and II: Thermal Pain | Up to 5 hours for part I and up to 56 hours for part II |
| Parts I and II: Electrical pain Stair and Burst | Up to 5 hours for part I and up to 56 hours for part II |
| Parts I and II: Pressure Pain | Up to 5 hours for part I and up to 56 hours for part II |
| Parts I and II: Cold Pressor | Up to 5 hours for part I and up to 56 hours for part II |
| Parts I and II: Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor) | Up to 5 hours for part I and up to 56 hours for part II |
| Parts I and II: Visual Analogue Scale Bond & Lader | Up to 5 hours for part I and up to 56 hours for part II |
| Parts I and II: Visual Analogue Scale Bowdle | Up to 5 hours for part I and up to 56 hours for part II |
| Part II only: Saccadic eye movement | Up to 56 hours |
| Part II only: Smooth pursuit eye movement | Up to 56 hours |
| Part II only: Adaptive tracking | Up to 56 hours |
| Part II only: Body sway | Up to 56 hours |
| Part II only: N-Back | Up to 56 hours |
| Part II only: Pharmaco-EEG: power | Up to 56 hours |
| Part II only: Pupillometry | Up to 56 hours |
| Part II only: 49-item Addiction Center Research Inventory | Up to 60 hours |
| Part II only: Bowel Function Index | Up to day 7 |
| Part II - Groups 2 and 3 only: Thermal pain (Normal skin and erythema skin - UVB) | Up to 24 hours |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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