Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objectives of this study are:

* To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450.
* To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and faeces.
* To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and Debio 1452 (active moiety) in plasma and urine.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body

NCT04771286

Healthy

COMPLETED PHASE1

A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293

NCT02126514

Healthy Volunteers Mass Balance Study

COMPLETED PHASE1

A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants

NCT03864601

Healthy

COMPLETED PHASE1

Mass Balance and Metabolism Study of 14C-Z-215

NCT02618629

Healthy Male Subjects

COMPLETED PHASE1

Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects

NCT06233916

Mass Balance Study

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: Cohort 1

Participants receive a single intravenous (IV) dose of 240 mg/3.7 megabecquerel (MBq) of \[14C-pos 1\]-Debio 1450 BES solution.

Group Type EXPERIMENTAL

[14C-pos 1]-Debio 1450 BES Solution

Intervention Type DRUG

A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1

Part A: Cohort 2

Participants receive a single oral dose of 240 mg/3.7 MBq of \[14C-pos 1\]-Debio 1450 BES solution.

Group Type EXPERIMENTAL

[14C-pos 1]-Debio 1450 BES Solution

Intervention Type DRUG

A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1

Part B: Cohort 3

Participants receive a single oral dose of 240 mg Debio 1450/37 kilobecquerel (kBq) of \[14C-pos 25\]-Debio 1450 BES solution.

Group Type EXPERIMENTAL

[14C-pos 25]-Debio 1450 BES Solution

Intervention Type DRUG

A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[14C-pos 1]-Debio 1450 BES Solution

A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1

Intervention Type DRUG

[14C-pos 25]-Debio 1450 BES Solution

A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
3. the analysis of results

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes