Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

Healthy Clinical Trial

Official title:

A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907149
• Other study ID #: GLPG3970-CL-107
• Secondary ID: 2021-000711-23
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2021
• Est. completion date: July 12, 2021

Study information

• Verified date: July 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 tablet and an oral solution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
• A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
• Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day). This list only contains the key inclusion criteria.

Exclusion Criteria:

• Participant has participated in a [14C]radiolabeled study within the past 12 months.
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 month or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study. This list only contains the key exclusion criteria.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG3970 film-coated tablet
Participants will receive a single oral dose of GLPG3970.
• [14C]GLPG3970 solution for infusion
Participants will receive an i.v. microtracer microdose.
• [14]GLPG3970 oral solution
Participants will receive a single oral dose [14C]GLPG3970.

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Ltd	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 [%]) of GLPG3970		From Day 1 pre-dose until Day 4 in Period 1
Primary	Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).		From Day 1 pre-dose until Day 8 in Period 2
Primary	Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).		From Day 1 pre-dose until Day 8 in Period 2
Secondary	Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.		From Day 1 through study completion, an average of 1 month