A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection

A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1972 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1972 Microtracer and Single Oral [14C]-GLPG1972 Administration

The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body.

The sponsor will also look at the safety and tolerability of the test medicine.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG1972 film-coated tablets; Drug: [14C]-GLPG1972 solution for infusion; Drug: [14C]-GLPG1972 oral solution

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF).
• A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
• Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator.
• Having a regular daily defecation pattern (i.e. 1 to 3 times per day).

Exclusion Criteria:

• Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
• History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
• Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first investigational medicinal product (IMP) administration.
• Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration.
• 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 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG1972 oral and [14C]-GLPG1972 IV; GLPG1972 film-coated tablet followed by [14C]-GLPG1972 solution for infusion	Drug: GLPG1972 film-coated tablets; single oral dose of GLPG1972; Drug: [14C]-GLPG1972 solution for infusion; a 15-minute IV infusion [14C]-GLPG1972
Experimental: [14C]-GLPG1972 oral solution	Drug: [14C]-GLPG1972 oral solution; single oral dose of [14C]-GLPG1972

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of total radioactivity excreted in urine and feces combined (Period 2)	To assess the mass balance, using [14C]-GLPG1972	From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2)	To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 10
Cmax of GLPG1972 (Period 2)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 10
Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 10
AUC of GLPG1972 (Period 2)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 10
Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2)	To characterize the elimination pathways and metabolite profile of GLPG1972	From Day 1 pre-dose up to Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
IV Cmax of total radioactivity (Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
IV AUC of [14C]-GLPG1972 MT (Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
IV AUC of total radioactivity (Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations (Period 1 and Period 2)	To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2)	From Day 1 through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Angela de Haas-Amatsaleh, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: GLPG1972-CL-108; 2019-001305-25 (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