A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3970

Phase 1

Completed

• Conditions: Healthy; Psoriasis
• Interventions: Drug: GLPG3970 oral solution; Drug: Placebo oral solution; Drug: GLPG3970 capsule

• Registration Number: NCT04106297
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-10
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Primary Completion: 2021-03-05
• Study Completion: 2021-03-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG3970 SAD	GLPG3970 oral solution	Single doses of GLPG3970 at up to 6 dose levels in ascending order
GLPG3970 MAD	GLPG3970 oral solution	Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days
Placebo SAD	Placebo oral solution	Single doses of placebo
Placebo MAD	Placebo oral solution	Multiple doses of placebo
GLPG3970 FE	GLPG3970 oral solution	Single dose of GLPG3970 in fed and fasted state
GLPG3970 FE-rBA	GLPG3970 capsule	Single dose of GLPG3970 in fed and fasted state
Placebo in psoriasis subjects	Placebo oral solution	-
GLPG3970 FE-rBA	GLPG3970 oral solution	Single dose of GLPG3970 in fed and fasted state
GLPG3970 in psoriasis subjects	GLPG3970 oral solution	-

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations	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 Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)	Between Day 1 pre-dose and Day 4	To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)	Between Day 1 pre-dose and Day 17	To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)	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
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)	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
Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis)	Between Day 1 pre-dose and Day 4	To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects
Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)	Between Day 1 pre-dose and Day 17	To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects
Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)	Between Day 1 pre-dose and Day 4	To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects
Area under curve (AUC) of GLPG3970 (Part 2)	Between Day 1 pre-dose and Day 17	To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE)	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
Area under curve (AUC) of GLPG3970 (Part 3, rBA)	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

Trial Locations

Locations (3)

Clinical Republican Hospital Arensia Experimental Medicine; 🇲🇩 Chisinau, Moldova, Republic of

ARENSIA Exploratory Medicine Unit; 🇺🇦 Kyiv, Ukraine

SGS Belgium NV - Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium