A Phase 1 interventional study of GLPG3667 capsule and [14C]-GLPG3667 solution for infusion in Healthy, sponsored by Lakefront Biotherapeutics NV. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Lakefront Biotherapeutics NV · Phase 1, Interventional, and Basic science
This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.
Lakefront Biotherapeutics NV is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Exclusion Criteria:
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Drug: GLPG3667 capsule · Drug: [14C]-GLPG3667 solution for infusion
Drug: [14C]-GLPG3667 capsule
On Day 1, participants will receive a single oral dose of GLPG3667
On Day 1, participants will receive a single microtracer microdose of \[14C\]-GLPG3667 as an intravenous infusion
On Day 1, participants will receive a single oral dose of \[14C\]-GLPG3667
Recovery of total radioactivity (TRA) excreted in urine expressed as a percentage of the administered dose (Ae%)
Time frame: From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in feces expressed as a percentage of the administered dose (Af%)
Time frame: From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in urine and feces expressed as a percentage of the administered dose (At%)
Time frame: From Day 1 until at least Day 8 in Period 2
Percentage of TRA in plasma and excreta for metabolites of interest
Time frame: From Day 1 until at least Day 8 in Period 2
Absolute oral bioavailability (F[percentage]) of GLPG3667
Time frame: From Day 1 until Day 4 in Period 1
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Time frame: From Day 1 through study completion, an average of 2 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cadefrecitinib
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