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
- Conditions
- Healthy
- Interventions
- Drug: GLPG1972 film-coated tabletsDrug: [14C]-GLPG1972 oral solutionDrug: [14C]-GLPG1972 solution for infusion
- Registration Number
- NCT04136327
- Lead Sponsor
- Galapagos NV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GLPG1972 oral and [14C]-GLPG1972 IV GLPG1972 film-coated tablets GLPG1972 film-coated tablet followed by \[14C\]-GLPG1972 solution for infusion GLPG1972 oral and [14C]-GLPG1972 IV [14C]-GLPG1972 solution for infusion GLPG1972 film-coated tablet followed by \[14C\]-GLPG1972 solution for infusion [14C]-GLPG1972 oral solution [14C]-GLPG1972 oral solution \[14C\]-GLPG1972 oral solution
- Primary Outcome Measures
Name Time Method Change of total radioactivity excreted in urine and feces combined (Period 2) From Day 1 pre-dose up to Day 10 To assess the mass balance, using \[14C\]-GLPG1972
Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2) From Day 1 pre-dose up to Day 10 To assess the PK of GLPG1972 and its main metabolites in plasma
Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2) From Day 1 pre-dose up to Day 7 To characterize the elimination pathways and metabolite profile of GLPG1972
Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2) From Day 1 pre-dose up to Day 10 To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma
Cmax of GLPG1972 (Period 2) From Day 1 pre-dose up to Day 10 To assess the PK of GLPG1972 and its main metabolites in plasma
AUC of GLPG1972 (Period 2) From Day 1 pre-dose up to Day 10 To assess the PK of GLPG1972 and its main metabolites in plasma
- Secondary Outcome Measures
Name Time Method IV Cmax of total radioactivity (Period 1) From Day 1 pre-dose up to Day 4 To assess the PK of GLPG1972 and its main metabolites in plasma
IV AUC of total radioactivity (Period 1) From Day 1 pre-dose up to Day 4 To assess the PK of GLPG1972 and its main metabolites in plasma
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 To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2)
IV AUC of [14C]-GLPG1972 MT (Period 1) From Day 1 pre-dose up to Day 4 To assess the PK of GLPG1972 and its main metabolites in plasma
Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1) From Day 1 pre-dose up to Day 4 To assess the PK of GLPG1972 and its main metabolites in plasma
Trial Locations
- Locations (1)
Quotient Sciences Limited
🇬🇧Nottingham, United Kingdom