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

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928343

Enrollment

Registered

2009-06-25

Start date

2009-06-30

Completion date

2009-12-31

Last updated

2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics

Brief summary

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.

Interventions

DRUGGLPG0187

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

DRUGPlacebo

Matching subcutaneous or oral placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of single subcutaneous and oral dosing	up to day 10 postdose

Secondary

Measure	Time frame
Pharmacokinetics of single subcutaneous and oral doses	up to 10 days postdose
Exploratory evaluation of S-CTX	up to 24 hrs postdose

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026