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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C-pos 1]-Debio 1450 BES Solution; Drug: [14C-pos 25]-Debio 1450 BES Solution

• Registration Number: NCT02595203
• Lead Sponsor: Debiopharm International SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Cohort 1	[14C-pos 1]-Debio 1450 BES Solution	Participants receive a single intravenous (IV) dose of 240 mg/3.7 megabecquerel (MBq) of \[14C-pos 1\]-Debio 1450 BES solution.
Part A: Cohort 2	[14C-pos 1]-Debio 1450 BES Solution	Participants receive a single oral dose of 240 mg/3.7 MBq of \[14C-pos 1\]-Debio 1450 BES solution.
Part B: Cohort 3	[14C-pos 25]-Debio 1450 BES Solution	Participants receive a single oral dose of 240 mg Debio 1450/37 kilobecquerel (kBq) of \[14C-pos 25\]-Debio 1450 BES solution.

Primary Outcome Measures

Name	Time	Method
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)
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)
Whole blood and plasma partitioning of total radioactivity after a single dose of radiolabelled Debio 1450 through measurement of total radioactivity levels in blood	168 hours after dosing (Day 8)	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
Percentage of participants with clinically significant change from baseline in vital signs, electrocardiogram, and/or laboratory parameters	168 hours after dosing (Day 8)

Trial Locations

Locations (1)

Covance Clinical Research Unit (CRU) Ltd.; 🇬🇧 Leeds, United Kingdom