SGS CPU
Antwerp, Belgium
NCT Number: NCT03143712
This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.
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Notify Me18 year–50 year
Male
Interventional
Phase 1
Antwerp, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administration of GLPG1690 in three different treatment conditions (treatment A through C)
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavailability of GLPG1690 by assessing PK parameters
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavialability of GLPG1690 by assessing PK parameters
Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavialability of GLPG1690 by assessing PK parameters
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
To assess safety and tolerability of GLPG1690
Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
To assess safety and tolerability of GLPG1690
Lakefront Biotherapeutics NV
Industry
An Open Label Study to Compare the Oral Bioavailability of a Tablet of GLPG1690 Relative to a Capsule After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Tablet
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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