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

ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).

Medical history

Physical examination

Neurological examination

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 14C-SEP-380135

    Drug

    Oral Capsule

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: 14C-SEP-380135Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Radioactivity Amount Excreted in Urine (Ae,u)

Time frame
Up to Day 8
2

Total Radioactivity Amount Excreted in Feces (Ae,f)

Time frame
Up to Day 8
3

Fraction of Dose Excreted in Urine (%fe,u)

Time frame
Up to Day 8
4

Fraction of Dose Excreted in Feces (%fe,f)

Time frame
Up to Day 8

Secondary outcomes

1

Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites

Time frame
Up to Day 8
2

Time for Cmax (tmax) of SEP-380135 and Metabolites

Time frame
Up to Day 8
3

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
4

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites

Time frame
Up to Day 8

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: