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Not yet recruiting NCT07455084

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

Phase I Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 14C-SEP-380135.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 14C-SEP-380135
    Oral Capsule

Primary outcome measures

  • Total Radioactivity Amount Excreted in Urine (Ae,u) [Time frame: Up to Day 8]
  • Total Radioactivity Amount Excreted in Feces (Ae,f) [Time frame: Up to Day 8]
  • Fraction of Dose Excreted in Urine (%fe,u) [Time frame: Up to Day 8]
  • Fraction of Dose Excreted in Feces (%fe,f) [Time frame: Up to Day 8]
Secondary outcome measures (12)
  • Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites [Time frame: Up to Day 8]
  • Time for Cmax (tmax) of SEP-380135 and Metabolites [Time frame: 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 [Time frame: Up to Day 8]
  • Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites [Time frame: Up to Day 8]
  • Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites [Time frame: Up to Day 8]
  • Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135 [Time frame: Up to Day 8]
  • Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135 [Time frame: Up to Day 8]
  • Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135 [Time frame: Up to Day 8]
  • Number of Participants with Adverse Events (AEs) [Time frame: Up to Day 31]
  • Number of Participants with Potentially Clinically Significant Changes in Vital Signs [Time frame: Upto Day 8]
  • Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters [Time frame: Upto Day 8]
  • Number of Participants With Potentially Clinically Significant Changes in Physical Examinations [Time frame: Upto Day 8]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Celerion, Inc. — Lincoln

Identifiers

NCT: NCT07455084 · 384-201-00003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗