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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023857-12 | EudraCT Number |
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This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BYK324677 | Active Comparator |
In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned. Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1. Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner. |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BYK324677 | Drug | capsules, administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers. | Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ [=PR], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis. | during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers. | Pharmacokinetic variables (e.g. AUC, Cmax, tmax, t1/2) of BYK324677 on Day 1 and Day 5 (single dose i.e. after first Investigational medicinal product (IMP) dose vs steady state) as well as on Day 4 and Day 5 (fed vs fasted, respectively). | during Treatment Period 1 and Period 2 (up to 3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed Investigational site | Mannheim | 68167 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers. | Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted). | during Treatment Period 1 and Period 2 (up to 3 weeks) |
| D004700 | Endocrine System Diseases |