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

NCT04136327 | Completed Phase 1

• 2 other identifiers: GLPG1972-CL-1082019-001305-25
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)

  From Day 1 pre-dose up to Day 4

• IV Cmax of total radioactivity (Period 1)

  From Day 1 pre-dose up to Day 4

• IV AUC of [14C]-GLPG1972 MT (Period 1)

  From Day 1 pre-dose up to Day 4

• IV AUC of total radioactivity (Period 1)

  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)

  From Day 1 through study completion, an average of 2 months

Study Arms (2)

GLPG1972 oral and [14C]-GLPG1972 IV

EXPERIMENTAL

GLPG1972 film-coated tablet followed by \[14C\]-GLPG1972 solution for infusion

Drug: GLPG1972 film-coated tablets; Drug: [14C]-GLPG1972 solution for infusion

[14C]-GLPG1972 oral solution

EXPERIMENTAL

\[14C\]-GLPG1972 oral solution

Drug: [14C]-GLPG1972 oral solution

Interventions

GLPG1972 film-coated tablets DRUG

single oral dose of GLPG1972

GLPG1972 oral and [14C]-GLPG1972 IV

[14C]-GLPG1972 solution for infusion DRUG

a 15-minute IV infusion \[14C\]-GLPG1972

GLPG1972 oral and [14C]-GLPG1972 IV

[14C]-GLPG1972 oral solution DRUG

single oral dose of \[14C\]-GLPG1972

[14C]-GLPG1972 oral solution

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Quotient Sciences Limited

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Angela de Haas-Amatsaleh, MD

  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: October 21, 2019
• First Posted: October 23, 2019
• Study Start: September 13, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)