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

NCT ID: NCT04136327

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-13
• Study Completion Date: 2019-10-21

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

GLPG1972 oral and [14C]-GLPG1972 IV

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

Group Type: EXPERIMENTAL

GLPG1972 film-coated tablets

Intervention Type: DRUG

single oral dose of GLPG1972

[14C]-GLPG1972 solution for infusion

Intervention Type: DRUG

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

[14C]-GLPG1972 oral solution

\[14C\]-GLPG1972 oral solution

Group Type: EXPERIMENTAL

[14C]-GLPG1972 oral solution

Intervention Type: DRUG

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

Interventions

GLPG1972 film-coated tablets

single oral dose of GLPG1972

Intervention Type: DRUG

[14C]-GLPG1972 solution for infusion

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

Intervention Type: DRUG

[14C]-GLPG1972 oral solution

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela de Haas-Amatsaleh, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Quotient Sciences Limited

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2019-001305-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG1972-CL-108

Identifier Type: -

Identifier Source: org_study_id