GLPG3970 oral solution
DrugGLPG3970 for oral administration
NCT Number: NCT04106297
The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
SGS Belgium NV - Clinical Pharmacology Unit Antwerp, Antwerp, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Part 1, 1bis, 2, 3 and 3bis:
This list only contains the key inclusion criteria for the healthy volunteers part of the study.
Inclusion criteria
for Part 4:
This list only contains the key inclusion criteria for Part 4 of the study.
Exclusion criteria
for Part 1, 1bis, 2, 3 and 3bis:
This list only contains the key exclusion criteria for the healthy volunteers part of the study.
Exclusion criteria
for Part 4:
This list only contains the key inclusion criteria for Part 4 of the study.
GLPG3970 for oral administration
Placebo for oral administration
GLPG3970 for oral administration
Time frame: From screening through study completion, an average of 20 months
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks
Time frame: Between Day 1 pre-dose and Day 4
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 17
To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 4
To evaluate the food effect on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
To evaluate the PK of a single oral dose of GLPG3970 administered as an oral solution versus and oral capsule in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 17
To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Time frame: Between Day 1 pre-dose and Day 4
To evaluate the food effect on the PK of a single oral dose of GLPG3970 under fed conditions (high-fat high calorie) versus fasted conditions in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
To evaluate the rBA of an oral solution of GLPG3970 versus an oral capsule of GLPG3970 on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 4
To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects
Time frame: Between Day 1 pre-dose and Day 17
To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects
Lakefront Biotherapeutics NV
Industry
A First-in-human, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GLPG3970 Single and Multiple Ascending Doses in Adult Healthy Male Subjects, and in Psoriasis Subjects When Administered Daily for 6 Weeks
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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