A Study in Healthy Male Volunteers to Look at How the Tes... | NCT03787186

Status Module

Label	Type	Description	Intervention Names
GLPG1690 oral and IV	Experimental	GLPG1690 film-coated tablets followed by [14C]-GLPG1690 solution for infusion	Drug: GLPG1690 film-coated tablets Drug: [14C]-GLPG1690 solution for infusion
[14C]-GLPG1690 capsules	Experimental	[14C]-GLPG1690 capsules	Drug: [14C]-GLPG1690 capsules

Name	Type	Description	Arm Group Labels	Other Names
GLPG1690 film-coated tablets	Drug	a single oral dose of GLPG1690	GLPG1690 oral and IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of total radioactivity excreted in urine and feces combined (µg) from baseline at Day 10 (Part 2)	To assess the mass balance using [14C]-GLPG1690.	From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of total radioactivity (Part 2).	To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma	From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of GLPG1690 (Part 2).	To assess the pharmacokinetics (PK) of GLPG1690 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 (Part 2).	To assess the PK of GLPG1690 and its main metabolites in plasma	From Day 1 pre-dose up to Day 10
Area under the plasma concentration-time curve (AUC) of GLPG1690 (Part 2).	To assess the PK of GLPG1690 and its main metabolites in plasma	From Day 1 pre-dose up to Day 10
Change in amount of [14C] GLPG1690 excreted in urine and feces combined (µg) from baseline at Day 7 (Part 2).	To better characterize the elimination pathways and metabolite profile of GLPG1690	From Day 1 pre-dose up to Day 7

Secondary Outcomes

Measure	Description	Time Frame
Intravenous (IV) maximum observed plasma concentration (Cmax) of [14C]-GLPG1690 microtracer (MT) (Part 1).	To assess the PK of GLPG1690 and its main metabolites in plasma.	From Day 1 pre-dose up to Day 4
Intravenous (IV) maximum observed plasma concentration (Cmax) of total radioactivity (Part 1).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to comply with the clinical study protocol (CSP) requirements and sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC), before any screening evaluations.
Male subjects between 30 to 64 years of age (extremes included), on the date of signing the ICF.
A body mass index between 18 to 32 kg/m2 (extremes included).
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, and not having had any clinically significant illness in the 3 months before first investigational medicinal product (IMP) administration.
Having a regular and (at least) daily defecation pattern.
Able and willing to comply with restrictions on prior and concomitant medication as described in the protocol.
Nonsmoker, defined as an individual who has abstained from smoking (or the use of e-cigarettes or nicotine containing products) from at least 2 months before screening. Having a breath carbon monoxide reading of ≤10 parts per million.
Negative urine drug screen (e.g. amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol breath test.
Male subjects with female partners of childbearing potential willing to comply with the contraceptive methods described in the protocol from the time of the first IMP administration, during the clinical study, and for at least 90 days after the last IMP administration.

Exclusion Criteria:

Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, such as anaphylaxis requiring hospitalization, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or history of hepatitis from any cause with the exception of a history of hepatitis A infection at least 12 weeks before first IMP administration.
History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min, using the Cockcroft-Gault formula), or other conditions known to interfere with the absorption, distribution, metabolism, and excretion (ADME) properties of drugs. Subjects with documented Gilbert's syndrome are eligible for inclusion in the study.
History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated and with no evidence of recurrence).
Hemoglobin level below the lower limit of normal (LLN; 13.0 g/dL). Retesting is allowed once.
Significant blood loss (including blood donation [>450 mL]) or transfusion of any blood product within 12 weeks before screening.
Active drug abuse (per investigator judgment) or alcohol abuse (more than three glasses of wine, beer, or equivalent/day) within 3 months before first IMP administration.
Concurrent participation or participation in a drug, drug/device or biologic investigational research study within 12 weeks or 5 half-lives of the drug, whichever is longer, before first IMP administration.
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic Xrays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.