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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Two-part, Open-label, Non-randomised Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C-pos 1]-Debio 1450 BES Solution
* Drug: [14C-pos 25]-Debio 1450 BES Solution


Participation Criteria
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Eligibility Criteria
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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: the safety or well-being of the participant or study staff the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) the analysis of results

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Cohort 1<br>Participants receive a single intravenous (IV) dose of 240 mg/3.7 megabecquerel (MBq) of [14C-pos 1]-Debio 1450 BES solution. | Drug: [14C-pos 1]-Debio 1450 BES Solution<br>* A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1<br>|
| Experimental: Part A: Cohort 2<br>Participants receive a single oral dose of 240 mg/3.7 MBq of [14C-pos 1]-Debio 1450 BES solution. | Drug: [14C-pos 1]-Debio 1450 BES Solution<br>* A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1<br>|
| Experimental: Part B: Cohort 3<br>Participants receive a single oral dose of 240 mg Debio 1450/37 kilobecquerel (kBq) of [14C-pos 25]-Debio 1450 BES solution. | Drug: [14C-pos 25]-Debio 1450 BES Solution<br>* A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery after a single dose of radiolabelled Debio 1450 measured through total radioactivity excreted in expired air, urine and faeces |  | 168 hours after dosing (Day 8) | 
| Routes of metabolism and excretion after a single dose of radiolabelled Debio 1450 measured through total radioactivity concentrations in expired air, urine and fecaes |  | 168 hours after dosing (Day 8) | 
| Whole blood and plasma partitioning of total radioactivity after a single dose of radiolabelled Debio 1450 through measurement of total radioactivity levels in blood | Blood is collected within the 168 hours as follows: IV infusion: Predose, 1, 1.85, 2.25, 2.5, 3, 4, 5, 8, 14, 18, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours after the infusion start time Oral administration: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours following the oral dose | 168 hours after dosing (Day 8) | 
| Percentage of participants with clinically significant change from baseline in vital signs, electrocardiogram, and/or laboratory parameters |  | 168 hours after dosing (Day 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability