Mass Balance Clinical Trial With TEV-56286

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2024-11-29

Brief Summary

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Mass balance clinical trial with TEV-56286

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Detailed Description

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Primary objectives:

* To investigate the mass balance and excretion of TEV-56286 following a single oral dose of \[14C\]-TEV-56286
* To assess the pharmacokinetics following a single oral dose of \[14C\]-TEV-56286

Secondary objective:

\- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration

The total duration of the clinical trial for each participant is expected to be approximately 59 days.

Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TEV-56286

Group Type EXPERIMENTAL

TEV-56286

Intervention Type DRUG

Oral capsule

[14C]-TEV-56286

Intervention Type DRUG

Oral capsule

Interventions

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TEV-56286

Oral capsule

Intervention Type DRUG

[14C]-TEV-56286

Oral capsule

Intervention Type DRUG

Other Intervention Names

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emrusolmin emrusolmin

Eligibility Criteria

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Inclusion Criteria

* No major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of the study drug, or surgery scheduled during the clinical trial including the follow-up period.
* No history of malignancy or treatment of malignancy in the last 5 years.
* No personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope of undetermined reason or previous treatment for high blood pressure.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

* History of relevant drug and/or food allergies.
* Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton \[excluding spinal column\]), during work, or during participation in a clinical trial in the period of 1 year prior to screening.

NOTE- Additional criteria apply, please contact the investigator for more information

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes