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

Healthy Clinical Trial

Official title:

Double-blind, Placebo-controlled, Dose-ranging Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Oral Doses, and Multiple Oral Doses of GLPG0778 in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278108
• Other study ID #: GLPG0778-CL-101
• Secondary ID: 2010-023199-16
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2011
• Last updated: October 17, 2011
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy male

• body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

• any condition that might interfere with the procedures or tests in the study

• smoking

• drug or alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0778
single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)
• placebo
single dose, oral solution or capsule (matching corresponding study medication)
• GLPG0778
multiple dose, capsule, 7 days
• placebo
multiple dose, capsule, 7 days

Locations

Country	Name	City	State
Belgium	SGS Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics of single and repeated doses, including effect of food.	Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).	up to 10 days postdose	No