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

Debiopharm

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [14C-pos 1]-Debio 1450 BES Solution; Drug: [14C-pos 25]-Debio 1450 BES Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02595203

2015-002604-87 (EudraCT Number)

Debio 1450-105

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Part A: Cohort 1

Experimental group

Description:

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

Treatment:

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

Part A: Cohort 2

Experimental group

Description:

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

Treatment:

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

Part B: Cohort 3

Experimental group

Description:

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

Treatment:

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