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Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

Sponsor
Galapagos NV (Industry)
Overall Status
Completed
CT.gov ID
NCT04704739
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
1.8
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: GLPG1205 film-coated tablets
  • Drug: [14C]-GLPG1205 solution for infusion
  • Drug: GLPG1205 capsules
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG1205 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1205 Microtracer and Single Oral [14C]-GLPG1205 Administration
Actual Study Start Date :
Jan 13, 2021
Actual Primary Completion Date :
Mar 2, 2021
Actual Study Completion Date :
Mar 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: GLPG1205 oral and [14C]-GLPG1205 IV

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

Drug: GLPG1205 film-coated tablets
Single oral dose of GLPG1205

Drug: [14C]-GLPG1205 solution for infusion
A 15-minute IV infusion of [14C]-GLPG1205
Experimental: [14C]-GLPG1205 capsule

Single oral dose of GLPG1205 as solid formulation

Drug: GLPG1205 capsules
Single oral dose of GLPG1205 as solid formulation

Outcome Measures

Primary Outcome Measures

  1. Absolute oral bioavailability (F) (%) [Between Day 1 and Day 22]

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

  2. Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%) [Between Day 1 and Day 22]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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).

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quotient Sciences Nottingham United Kingdom NG11 6JS

Sponsors and Collaborators

  • Galapagos NV

Investigators

  • Study Director: Ekaterina Tankisheva, MD, Galapagos NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT04704739
Other Study ID Numbers:
  • GLPG1205-CL-109
  • 2020-004550-29
First Posted:
Jan 12, 2021
Last Update Posted:
Mar 25, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 25, 2021