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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Galapagos NV
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
GLPG3970 in psoriasis subjects
Intervention: GLPG3970 oral solution (Drug)
GLPG3970 SAD
Single doses of GLPG3970 at up to 6 dose levels in ascending order
Intervention: GLPG3970 oral solution (Drug)
Placebo SAD
Single doses of placebo
Intervention: Placebo oral solution (Drug)
GLPG3970 MAD
Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days
Intervention: GLPG3970 oral solution (Drug)
Placebo MAD
Multiple doses of placebo
Intervention: Placebo oral solution (Drug)
GLPG3970 FE-rBA
Single dose of GLPG3970 in fed and fasted state
Intervention: GLPG3970 oral solution (Drug)
GLPG3970 FE-rBA
Single dose of GLPG3970 in fed and fasted state
Intervention: GLPG3970 capsule (Drug)
GLPG3970 FE
Single dose of GLPG3970 in fed and fasted state
Intervention: GLPG3970 oral solution (Drug)
Placebo in psoriasis subjects
Intervention: Placebo oral solution (Drug)
Outcomes
Primary Outcomes
Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
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
Secondary Outcomes
- Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)(Between Day 1 pre-dose and Day 4)
- Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)(Between Day 1 pre-dose and Day 17)
- Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)(Between Day 1 pre-dose and Day 4)
- Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)(Between Day 1 pre-dose and Day 4)
- Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis)(Between Day 1 pre-dose and Day 4)
- Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)(Between Day 1 pre-dose and Day 17)
- Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)(Between Day 1 pre-dose and Day 4)
- Area under curve (AUC) of GLPG3970 (Part 2)(Between Day 1 pre-dose and Day 17)
- Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE)(Between Day 1 pre-dose and Day 4)
- Area under curve (AUC) of GLPG3970 (Part 3, rBA)(Between Day 1 pre-dose and Day 4)