Clinical trial NCT04136327: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2019-10-23
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change of total radioactivity excreted in urine and feces combined (Period 2)
timeFrame: From Day 1 pre-dose up to Day 10
measure: Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2)
timeFrame: From Day 1 pre-dose up to Day 10
measure: Cmax of GLPG1972 (Period 2)
timeFrame: From Day 1 pre-dose up to Day 10
measure: Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2)
timeFrame: From Day 1 pre-dose up to Day 10
measure: AUC of GLPG1972 (Period 2)
timeFrame: From Day 1 pre-dose up to Day 10
measure: Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2)
timeFrame: From Day 1 pre-dose up to Day 7
Secondary outcomes:
measure: Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)
timeFrame: From Day 1 pre-dose up to Day 4
measure: IV Cmax of total radioactivity (Period 1)
timeFrame: From Day 1 pre-dose up to Day 4
measure: IV AUC of [14C]-GLPG1972 MT (Period 1)
timeFrame: From Day 1 pre-dose up to Day 4
measure: IV AUC of total radioactivity (Period 1)
timeFrame: From Day 1 pre-dose up to Day 4
measure: 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)
timeFrame: From Day 1 through study completion, an average of 2 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Limited
Study officials:
affiliation: Galapagos NV
name: Angela de Haas-Amatsaleh, MD
role: STUDY_DIRECTOR
References: