First-in-Human Single Ascending and Multiple Dose of GLPG0634

NCT01179581 | Completed Phase 1

• 2 other identifiers: GLPG0634-CL-1012010-018440-14
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food). Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Conditions

Healthy

Keywords

Safety; Tolerability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of single and multiple dosing

  Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.

  up to 10 days postdose

Secondary Outcomes (1)

• Pharmacokinetics of single and repeated doses, including effect of food.

  up to 10 days postdose

Study Arms (4)

1

EXPERIMENTAL

single ascending doses

Drug: GLPG0634

2

PLACEBO COMPARATOR

single dose placebo

Drug: placebo

3

EXPERIMENTAL

multiple dose, 10 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).

Drug: GLPG0634

4

PLACEBO COMPARATOR

multiple dose, capsules, 10 days; scheme to match that of Study Arm 3.

Drug: placebo

Interventions

GLPG0634 DRUG

single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)

1

placebo DRUG

single dose, oral solution or capsule (matching corresponding study medication)

2

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male, age 40-60 years
• body mass index (BMI) between 18-30 kg/m², inclusive.

You may not qualify if:

• any condition that might interfere with the procedures or tests in the study
• smoking
• drug or alcohol abuse

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS Stuivenberg

Antwerp, Belgium

Location

Related Publications (1)

• Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.

  PMID: 25681059 DERIVED

MeSH Terms

Interventions

GLPG0634

Study Officials

• Gerben van 't Klooster, PhD

  Galapagos NV

  STUDY DIRECTOR

• Eva Vets, MD

  SGS Stuivenberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 24, 2011

Record last verified: 2011-03

Locations

BE (1)