Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG1205 capsules; Drug: [14C]-GLPG1205 solution for infusion; Drug: GLPG1205 film-coated tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT04704739

2020-004550-29 (EudraCT Number)

GLPG1205-CL-109

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

GLPG1205 oral and [14C]-GLPG1205 IV

Experimental group

Description:

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

Treatment:

Drug: GLPG1205 film-coated tablets

Drug: [14C]-GLPG1205 solution for infusion

[14C]-GLPG1205 capsule

Experimental group

Description:

Single oral dose of GLPG1205 as solid formulation

Treatment:

Drug: GLPG1205 capsules