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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011335-13 | EudraCT Number |
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This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.
Objectives:
This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNX-001 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNX-001 | Drug | 3.6, 7.2, or 10.8 mg single dose or t.i.w. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relationship of clinical safety measurements to dose | Adverse events (AEs), vital signs, electrocardiogram (ECG), Acetylcholinesterase (AChE) inhibition, laboratory parameters after single and multiple dose administration | Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of dose on pharmacokinetic (PK) parameters | Pharmacokinetic parameters after single and multiple dose administration of SNX-001 (3.6, 7.2 and 10.8 mg) | After single (Day 1) and multiple (Day 12) doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorg Sahlmann, MD | Scope Life Sciences GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scope Life Sciences GmbH | Hamburg | Germany |
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| ID | Term |
|---|---|
| C005109 | methanesulfonyl fluoride |
| D009821 | Oils |
| ID | Term |
|---|---|
| D008055 | Lipids |
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| Placebo | Drug | Same volumes and frequency as active. |
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