A Phase 1 interventional study of GLPG2737 single dose and Placebo single dose in Healthy, sponsored by Lakefront Biotherapeutics NV. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-25.
Sponsored by Lakefront Biotherapeutics NV · Phase 1, Interventional, and Basic science
This study is a first-in-human (FIH), Phase I, single center, randomized, double-blind, placebo-controlled, sequential group study in healthy male subjects to assess the safety, tolerability and PK of single ascending oral doses of GLPG2737 and multiple ascending oral doses of GLPG2737 administered for 14 days.
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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Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and clinical safety laboratory tests prior to the initial study drug administration.
Clinical safety laboratory test results must be within the laboratory reference ranges for males or test results that are outside the reference ranges for males need to be considered non clinically significant in the opinion of the investigator. One retest is allowed if deemed appropriate by the investigator.
Liver function tests must meet the following criteria:
Exclusion Criteria:
Single doses of GLPG2737 oral suspension at up to 5 dose levels in ascending order
Drug: GLPG2737 single dose
Single doses of Placebo oral suspension
Drug: Placebo single dose
Multiple doses of GLPG2737 oral suspension at up to 3 dose levels in ascending order
Drug: GLPG2737 multiple dose
Multiple doses of Placebo oral suspension
Drug: GLPG2737 multiple dose
GLPG2737 oral suspension, single ascending doses
Placebo, oral suspension.
GLPG2737 oral suspension, multiple ascending doses, daily for 14 days.
Placebo, oral suspension, daily for 14 days
Change versus placebo in the proportion of subjects with adverse events
To assess safety and tolerability of single and multiple ascending doses with GLPG2737 versus placebo in healthy subjects.
Time frame: Between screening and 14 days (SAD part) and 15 days (MAD part) after the last dose
Maximum observed plasma concentration (Cmax) of GLPG2737
To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects
Time frame: Between Day 1 predose and 5 days after the last dose
Time of occurrence of Cmax for GLPG2737 (tmax)
To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects
Time frame: Between Day 1 predose and 5 days after the last dose
Area under the plasma concentration-time curve (AUC0-t) of GLPG2737
To characterize pharmacokinetics of GLPG2737 and its metabolites after single and multiple oral doses in healthy subjects
Time frame: Between Day 1 predose and 5 days after the last dose
Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects
To explore the potential of CYP3A4 interaction with GLPG2737
Time frame: Day 1 predose and Day 14
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GLPG-2737
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