Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

NCT04907149 | Completed Phase 1

• 2 other identifiers: GLPG3970-CL-1072021-000711-23
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 tablet and an oral solution.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Absolute oral bioavailability (F [%]) of GLPG3970

  From Day 1 pre-dose until Day 4 in Period 1

• 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

• 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 Outcomes (1)

• 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

Study Arms (2)

Absolute Bioavailability - Period 1

EXPERIMENTAL

Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of \[14C\]GLPG3970 on Day 1.

Drug: GLPG3970 film-coated tablet; Drug: [14C]GLPG3970 solution for infusion

Mass Balance - Period 2

EXPERIMENTAL

Participants will receive \[14C\]GLPG397 under fasted conditions on Day 1.

Drug: [14]GLPG3970 oral solution

Interventions

GLPG3970 film-coated tablet DRUG

Participants will receive a single oral dose of GLPG3970.

Absolute Bioavailability - Period 1

[14C]GLPG3970 solution for infusion DRUG

Participants will receive an i.v. microtracer microdose.

Absolute Bioavailability - Period 1

[14]GLPG3970 oral solution DRUG

Participants will receive a single oral dose \[14C\]GLPG3970.

Mass Balance - Period 2

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Quotient Sciences Ltd

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Ekaterina Tankisheva

  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: May 26, 2021
• First Posted: May 28, 2021
• Study Start: June 7, 2021
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)