NCT04704739

Brief Summary

A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a capsule or tablet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

January 8, 2021

Last Update Submit

March 24, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Absolute oral bioavailability (F) (%)

    To determine the absolute bioavailability of an oral dose of GLPG1205 relative to an intravenous (i.v.) microtracer dose of \[14C\]-GLPG1205

    Between Day 1 and Day 22

  • Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%)

    To assess the mass balance recovery after a single oral dose of \[14C\]-GLPG1205

    Between Day 1 and Day 22

Study Arms (2)

GLPG1205 oral and [14C]-GLPG1205 IV

EXPERIMENTAL

Single oral dose of GLPG1205 followed by \[14C\]-GLPG1205 solution for infusion

Drug: GLPG1205 film-coated tabletsDrug: [14C]-GLPG1205 solution for infusion

[14C]-GLPG1205 capsule

EXPERIMENTAL

Single oral dose of GLPG1205 as solid formulation

Drug: GLPG1205 capsules

Interventions

GLPG1205 film-coated tabletsDRUG

Single oral dose of GLPG1205

GLPG1205 oral and [14C]-GLPG1205 IV
[14C]-GLPG1205 solution for infusionDRUG

A 15-minute IV infusion of \[14C\]-GLPG1205

GLPG1205 oral and [14C]-GLPG1205 IV
GLPG1205 capsulesDRUG

Single oral dose of GLPG1205 as solid formulation

[14C]-GLPG1205 capsule

Eligibility Criteria

Age18 Years - 64 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male between 18-64 years of age (extremes included) (Part 1) and between 45-64 years of age (extremes included) (Part 2), on the date of signing the informed consent form.
  • A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
  • Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).

You may not qualify if:

  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, cannot participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

GLPG1205

Study Officials

  • Ekaterina Tankisheva, MD

    Galapagos NV

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 12, 2021

Study Start

January 13, 2021

Primary Completion

March 2, 2021

Study Completion

March 10, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)