Safety Issues, Tolerance
Conditions
Brief summary
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
Interventions
DRUGLPH-5
LPH-5
DRUGPlacebo
Placebo
Sponsors
Biotrial
Lophora
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, and clinical laboratory evaluations.
Exclusion criteria
* Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study, or would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the clinical study, as determined by the Investigator. * Have a history of and/or current clinically significant determined by the Investigator * Consumes cannabis or cannabis-derived compounds more than 3 times per month or has substantial changes in cannabis consumption in the 21 days prior to screening.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameters - AUC0-∞ | Time Frame: 0-48 hours | Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours) |
| Pharmacokinetics parameters - AUC0-24h | Time Frame: 0-48 hours | Plasma PK concentrations including but not limited to: AUC from zero to 24 hours (AUC0-24h) (ng/ml x hours) |
| Pharmacokinetics parameters - AUC0-48h | Time Frame: 0-48 hours | Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours) |
| Pharmacokinetics parameters - Cmax | Time Frame: 0-48 hours | Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml) |
| 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) | Time Frame: 0-48 hours | Power spectral analysis of absolute and/or relative amplitude in the various frequency bands. |
| Pharmacokinetics parameters - half life | Time Frame: 0-48 hours | Plasma PK concentrations including but not limited to: half life (t1/2) (hours) |
| Pharmacokinetics parameters - tmax | Time Frame: 0-48 hours | Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes) |
| Pharmacokinetics parameters - AUC0-t | Time Frame: 0-48 hours | 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) |
Contacts
Primary ContactMikael Thomsen, PhD
Backup ContactJesper Kristensen, PhD
Outcome results
None listed