First-in-Human Single Ascending and Multiple Dose of GLPG0778

NCT01278108 | Completed Phase 1

• 2 other identifiers: GLPG0778-CL-1012010-023199-16
• Study Type: interventional
• Target: 40
• 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 GLPG0778 compared to placebo (with and without food). Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 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: GLPG0778

2

PLACEBO COMPARATOR

single dose placebo

Drug: placebo

3

EXPERIMENTAL

multiple dose, 7 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).

Drug: GLPG0778

4

PLACEBO COMPARATOR

multiple dose, capsules, 7 days; scheme to match that of Study Arm 3.

Drug: placebo

Interventions

GLPG0778 DRUG

single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)

1

placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male
• 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, 2060, Belgium

Location

Study Officials

• Gerben van 't Klooster, PhD

  Galapagos NV

  STUDY DIRECTOR

• Lien Gheyle, 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 18, 2011

Record last verified: 2011-10

Locations

BE (1)