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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136327
• Other study ID #: GLPG1972-CL-108
• Secondary ID: 2019-001305-25
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2019
• Est. completion date: October 21, 2019

Study information

• Verified date: November 2019
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG1972 film-coated tablets
single oral dose of GLPG1972
• [14C]-GLPG1972 solution for infusion
a 15-minute IV infusion [14C]-GLPG1972
• [14C]-GLPG1972 oral solution
single oral dose of [14C]-GLPG1972

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Limited	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
Secondary	IV Cmax of total radioactivity (Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
Secondary	IV AUC of [14C]-GLPG1972 MT (Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
Secondary	IV AUC of total radioactivity (Period 1)	To assess the PK of GLPG1972 and its main metabolites in plasma	From Day 1 pre-dose up to Day 4
Secondary	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)	To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2)	From Day 1 through study completion, an average of 2 months