First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

Lakefront Biotherapeutics NV18 enrolled

Overview

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

GLPG0187DRUG

Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)

PlaceboDRUG

Matching subcutaneous or oral placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male, age 18-50 years * BMI between 18-30 kg/m², inclusive Exclusion Criteria: * significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse

Locations (1)

SGS Stuivenberg

Antwerp, Belgium

Outcomes

Primary Outcomes

Safety and tolerability of single subcutaneous and oral dosing

Time frame: up to day 10 postdose

Secondary Outcomes

Pharmacokinetics of single subcutaneous and oral doses

Time frame: up to 10 days postdose

Exploratory evaluation of S-CTX

Time frame: up to 24 hrs postdose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.