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| Name | Class |
|---|---|
| Biotrial | INDUSTRY |
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This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | LPH-5_dose 1, single dose |
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| Cohort 2 | Experimental | LPH-5_dose 2, single dose |
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| Cohort 3 | Experimental | LPH-5_dose 3, single dose |
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| Cohort 4 | Experimental | LPH-5_dose 4, single dose |
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| Cohort 5 | Experimental | LPH-5_dose 5, single dose |
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| Cohort 6 | Experimental | LPH-5_dose 6, single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPH-5 | Drug | LPH-5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Through study completion, an average of 1 year | |
| Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results | Through study completion, an average of 1 year | |
| Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters - Cmax | Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml) | Time Frame: 0-48 hours |
| Pharmacokinetics parameters - tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikael Thomsen, PhD | Contact | 23276134 | mik.thomsen@gmail.com | |
| Jesper Kristensen, PhD | Contact | 25709521 | jk@lophora.com |
| Name | Affiliation | Role |
|---|---|---|
| Sophie Hays, MD | Biotrial | Principal Investigator |
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| Placebo | Drug | Placebo |
|
Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)
| Time Frame: 0-48 hours |
| Pharmacokinetics parameters - AUC0-t | Plasma PK concentrations including but not limited to: area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) (ng/ml x hours) | Time Frame: 0-48 hours |
| Pharmacokinetics parameters - AUC0-∞ | Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours) | Time Frame: 0-48 hours |
| Pharmacokinetics parameters - AUC0-24h | Plasma PK concentrations including but not limited to: AUC from zero to 24 hours (AUC0-24h) (ng/ml x hours) | Time Frame: 0-48 hours |
| Pharmacokinetics parameters - AUC0-48h | Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours) | Time Frame: 0-48 hours |
| Pharmacokinetics parameters - half life | Plasma PK concentrations including but not limited to: half life (t1/2) (hours) | Time Frame: 0-48 hours |
| Pharmacodynamic parameter - assessing the mood and subjective effects of single ascending doses of LPH-5 in healthy participants in questionnaires | Time Frame: 0-48 hours |
| Pharmacodynamic parameter - Pharmaco-EEG (qEEG) | Power spectral analysis of absolute and/or relative amplitude in the various frequency bands. | Time Frame: 0-48 hours |