Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

Официальное название

An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

Обзор

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.

Вмешательства

• Препарат 5 Methoxy N,N Dimethyltryptamine
  GH001 administered via inhalation

Первичные конечные точки

• Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUC0-∞) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - terminal elimination rate constant (λz) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - apparent total body clearance (CL/F) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - apparent steady-state volume of distribution (VSS/F) [Срок оценки: Up to 6 hours]
• Serum PK parameters of mebufotenin - Cmax/AUC0-∞ [Срок оценки: Up to 6 hours]
• Safety and tolerability: incidence of treatment-emergent adverse events [Срок оценки: Up to 7 days]

Критерии участия

Критерии включения

• Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening
• Good mental health in the opinion of the investigator.
• Normal spirometry (FEV1 of >80% of predicted and FVC of >80% of predicted value) at screening.

Критерии исключения

• Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.
• Has received any investigational medication, including investigational vaccines, in the 3 months prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.
• Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• GH Research Clinical Trial Site — London

Идентификаторы

NCT: NCT06511947 · GH001-HV-106-2 · IRAS Number

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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