LPH-5
DrugLPH-5
Not Yet Recruiting
NCT Number: NCT06722820
Study to Evaluate LPH-5 in Healthy Subjects
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
DrugPlacebo
Primary outcomes
-
Incidence and severity of adverse events (AEs)
Time frame: Through study completion, an average of 1 year
-
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time frame: Through study completion, an average of 1 year
-
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination
Time frame: Through study completion, an average of 1 year
Secondary outcomes
-
Pharmacokinetics parameters - Cmax
Time frame: Time Frame: 0-48 hours
Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)
-
Pharmacokinetics parameters - tmax
Time frame: 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: 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)
-
Pharmacokinetics parameters - AUC0-∞
Time frame: 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: 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: 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 - half life
Time frame: Time Frame: 0-48 hours
Plasma PK concentrations including but not limited to: half life (t1/2) (hours)
-
Pharmacodynamic parameter - assessing the mood and subjective effects of single ascending doses of LPH-5 in healthy participants in questionnaires
Time frame: Time Frame: 0-48 hours
-
Pharmacodynamic parameter - Pharmaco-EEG (qEEG)
Time frame: Time Frame: 0-48 hours
Power spectral analysis of absolute and/or relative amplitude in the various frequency bands.
Study contacts
Contact information is provided by the study sponsor or research team.
Jesper Kristensen, PhD
CONTACT
Mikael Thomsen, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Lophora
Industry
Collaborators
- Biotrial
Registry information
Official study title
Phase I, First-in-man, Randomised, Placebo-controlled, Single Dose Escalation Study to Investigate the Effects of LPH-5 on Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Parameters in Healthy Participants
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Dec 9, 2024
- Registry last updated
- Dec 9, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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