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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000327-24 | EudraCT Number |
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The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral dose LNP1892 in healthy males and female subjects
This is first in human, Phase 1 study. Primary purpose is to assess safety, tolerability, pharmacodynamic and pharmacokinetic of the LNP1892. Study will be conducted in healthy human subjects. Pharmacokinetic will be studied in the subjects after administration of single and multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNP1892 | Experimental | Dosage Form: Tablet Two Parts. Part A: Single Ascending Dose (SAD) starting with 25 mg (Maximum 5 cohorts). Part B: Multiple Ascending Dose (MAD), 10 days dosing, Maximum 3 cohorts. Six subjects in each cohort will receive LNP1892 |
|
| Placebo | Placebo Comparator | Two subjects in each cohort will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNP1892 | Drug | Tablets of two strengths (5 and 25 mg) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of single and multiple oral doses of LNP1892 in healthy subjects | Up to 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the single and multiple oral dose pharmacokinetics of LNP1892 in healthy subjects | Pre-dose to 72 hours post last dose | |
| To determine the single and multiple oral dose pharmacodynamics of LNP1892 in healthy subjects. | Pre-dose to 72 hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objectives: To determine the effect of food on the single oral dose pharmacokinetics of LNP1892 in healthy subjects | Pre-dose to 72 hours post last dose | |
| Exploratory Objectives: To determine the effect of gender on the single oral dose pharmacokinetics of LNP1892 in healthy subjects |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, MB ChB, PhD | Covance | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd. Springfield House Hyde Street | Leeds | LS2 9LH | United Kingdom |
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| Drug |
Matching placebo |
|
| Pre-dose to 72 hours post last dose |