Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

July 22, 2021 updated by: Galapagos NV

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • Quotient Sciences Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Absolute Bioavailability - Period 1
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
Participants will receive a single oral dose of GLPG3970.
Drug: [14C]GLPG3970 solution for infusion
Participants will receive an i.v. microtracer microdose.
Experimental: Mass Balance - Period 2
Participants will receive [14C]GLPG397 under fasted conditions on Day 1.
Drug: [14]GLPG3970 oral solution
Participants will receive a single oral dose [14C]GLPG3970.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute oral bioavailability (F [%]) of GLPG3970
Time Frame: From Day 1 pre-dose until Day 4 in Period 1
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%).
Time Frame: From Day 1 pre-dose until Day 8 in Period 2
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%).
Time Frame: From Day 1 pre-dose until Day 8 in Period 2
From Day 1 pre-dose until Day 8 in Period 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Time Frame: From Day 1 through study completion, an average of 1 month
From Day 1 through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Investigators

  • Study Director: Ekaterina Tankisheva, Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Actual)

July 12, 2021

Study Completion (Actual)

July 12, 2021

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLPG3970-CL-107
  • 2021-000711-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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