Quotient Sciences Limited
Nottingham, NG11 6JS, United Kingdom
NCT Number: NCT04136327
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.
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Notify Me30 year–64 year
Male
Interventional
Phase 1
Nottingham, NG11 6JS, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single oral dose of GLPG1972
a 15-minute IV infusion [14C]-GLPG1972
single oral dose of [14C]-GLPG1972
Time frame: From Day 1 pre-dose up to Day 10
To assess the mass balance, using [14C]-GLPG1972
Time frame: From Day 1 pre-dose up to Day 10
To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 7
To characterize the elimination pathways and metabolite profile of GLPG1972
Time frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 4
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 through study completion, an average of 2 months
To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2)
Lakefront Biotherapeutics NV
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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