NCT02595203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

November 2, 2015

Last Update Submit

January 14, 2016

Conditions

Healthy

Keywords

Bioavailability

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (3)

Part A: Cohort 1

EXPERIMENTAL

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

Part A: Cohort 2

EXPERIMENTAL

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

Part B: Cohort 3

EXPERIMENTAL

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

Interventions

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

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

Part A: Cohort 1Part A: Cohort 2
[14C-pos 25]-Debio 1450 BES SolutionDRUG

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

Part B: Cohort 3

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

  • Annick Ménétrey

    Debiopharm International, S.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 3, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

GB(1)