Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704739
• Other study ID #: GLPG1205-CL-109
• Secondary ID: 2020-004550-29
• Status: Completed
• Phase: Phase 1
• Start date: January 13, 2021
• Est. completion date: March 10, 2021

Study information

• Verified date: March 2021
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 10, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG1205 film-coated tablets
Single oral dose of GLPG1205
• [14C]-GLPG1205 solution for infusion
A 15-minute IV infusion of [14C]-GLPG1205
• GLPG1205 capsules
Single oral dose of GLPG1205 as solid formulation

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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