SGS Belgium Life Sciences
Antwerp, Belgium
NCT Number: NCT03143725
This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet relative to an oral solution and to the oral direct compression (DC) tablet after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the WG 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 GLPG1972 in four different treatment conditions (Treatments A throug D)
Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: At 24 hours post dose
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses
Determine bioavailability of GLPG1972 by assessing PK parameters
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
To assess safety and tolerability of GLPG1972 given orally
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
To assess safety and tolerability of GLPG1972 given orally
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
To assess safety and tolerability of GLPG1972 given orally
Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
To assess safety and tolerability of GLPG1972 given orally
Lakefront Biotherapeutics NV
Industry
Open-label Study to Compare the Bioavailability of an Oral Wet Granulation Tablet of GLPG1972 Relative to an Oral Solution and to an Oral Direct Compression Tablet After Single-dose Intake in Healthy Subjects, and to Evaluate the Effect of Food on the Bioavailability of an Oral Wet Granulation Tablet.
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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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