Clinical trial NCT02595203: Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 18
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mass balance recovery after a single dose of radiolabelled Debio 1450 measured through total radioactivity excreted in expired air, urine and faeces
timeFrame: 168 hours after dosing (Day 8)
measure: Routes of metabolism and excretion after a single dose of radiolabelled Debio 1450 measured through total radioactivity concentrations in expired air, urine and fecaes
timeFrame: 168 hours after dosing (Day 8)
measure: Whole blood and plasma partitioning of total radioactivity after a single dose of radiolabelled Debio 1450 through measurement of total radioactivity levels in blood
timeFrame: 168 hours after dosing (Day 8)
measure: Percentage of participants with clinically significant change from baseline in vital signs, electrocardiogram, and/or laboratory parameters
timeFrame: 168 hours after dosing (Day 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit (CRU) Ltd.
Study officials:
affiliation: Debiopharm International, S.A.
name: Annick Ménétrey
role: STUDY_DIRECTOR
References: