Quotient Sciences Limited
Nottingham, NG11 6JS, United Kingdom
NCT Number: NCT04137341
The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.
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Notify Me18 year–55 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
Film-coated tablet, formulation A
Film-coated tablet, formulation B
Film-coated tablet, formulation C
Time frame: From Day 1 pre-dose up to Day 4
To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972
Time frame: From Day 1 pre-dose up to Day 4
To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972
Time frame: From Day 1 pre-dose up to Day 4
To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972
Time frame: From Day 1 pre-dose up to Day 4
To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972
Time frame: From Day 1 pre-dose up to Day 4
To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972
Time frame: From Day 1 pre-dose up to Day 4
To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972
Time frame: From Day 1 through study completion, an average of 2 months
To evaluate the safety and tolerability of oral doses of GLPG1972 tablet formulations
Lakefront Biotherapeutics NV
Industry
A Randomized, Open-label, Four-period, Single-dose Cross-over Study in Healthy Male Subjects to Assess the Relative Bioavailability of Two Candidate Tablet Formulations Versus the Current Tablet Formulation of GLPG1972 and to Assess the Food Effect of the Tablet Formulation Selected for Phase 3 in Period 4
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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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