A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults

Официальное название

A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults

Обзор

The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.

Вмешательства

• Препарат 14C-SEP-380135
  Oral Capsule

Первичные конечные точки

• Total Radioactivity Amount Excreted in Urine (Ae,u) [Срок оценки: Up to Day 8]
• Total Radioactivity Amount Excreted in Feces (Ae,f) [Срок оценки: Up to Day 8]
• Fraction of Dose Excreted in Urine (%fe,u) [Срок оценки: Up to Day 8]
• Fraction of Dose Excreted in Feces (%fe,f) [Срок оценки: Up to Day 8]

Вторичные конечные точки (12)

• Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites [Срок оценки: Up to Day 8]
• Time for Cmax (tmax) of SEP-380135 and Metabolites [Срок оценки: Up to Day 8]
• Area Under the Concentration-Time Curve From Time Zero to the Last Observable Concentration at Time (AUCt) of SEP-380135 and Metabolites [Срок оценки: Up to Day 8]
• Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites [Срок оценки: Up to Day 8]
• Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites [Срок оценки: Up to Day 8]
• Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135 [Срок оценки: Up to Day 8]
• Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135 [Срок оценки: Up to Day 8]
• Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135 [Срок оценки: Up to Day 8]
• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to Day 31]
• Number of Participants with Potentially Clinically Significant Changes in Vital Signs [Срок оценки: Upto Day 8]
• Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters [Срок оценки: Upto Day 8]
• Number of Participants With Potentially Clinically Significant Changes in Physical Examinations [Срок оценки: Upto Day 8]

Критерии участия

Критерии включения

• Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
• In good overall health, based on:

• Medical history
• Physical examination
• Neurological examination
• Vital signs
• Electrocardiogram (ECG)
• Blood and urine tests (serum chemistry, hematology, urinalysis, serology)
• Regular daily bowel movements (at least one per day) for 30 days before Day -2.
• Ability to provide written informed consent and follow all study instructions.
• Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay.

Критерии исключения

• Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
• Have had prior exposure to SEP-380135.
• Are currently participating in another clinical trial.
• Attempted suicide within 12 months prior to screening.
• A history of sick sinus syndrome, any degree of atrioventricular block, Heart attack (myocardial infarction), heart failure (NYHA Class II-IV), cardiomyopathy, pulmonary congestion, cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.
• Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/exclusion criteria may apply.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Celerion, Inc. — Lincoln

Идентификаторы

NCT: NCT07455084 · 384-201-00003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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