Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

NCT01665924 | Completed Phase 1

• 1 other identifier: GLPG0634-CL-104
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the amount of compound present in the blood (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy subjects. During the course of the study, the effect of aging on the pharmacokinetics as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy subjects will be characterized.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634

  To characterize the amount of GLPG0634 in plasma over time - pharmacokinetics (PK) - after single and multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging

  From predose (before first study drug administration) up to 72 hours post last study drug administration

Secondary Outcomes (7)

• The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634

  From predose (before first study drug administration) up to 24 hours post last study drug administration

• Number of adverse events

  From screening up to 10 days after the last study drug administration

• Changes in vital signs as measured by heart rate, blood pressure and body temperature

  From screening up to 10 days after the last study drug administration

• Changes in 12-lead ECG measures

  From screening up to 10 days after the last study drug administration

• Changes in physical exam measures

  From screening up to 10 days after the last study drug administration

Study Arms (3)

40-50 years old

EXPERIMENTAL

GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old

Drug: GLPG0634 100mg capsule once a day for 10 days

65-74 years old

EXPERIMENTAL

GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old

Drug: GLPG0634 100mg capsule once a day for 10 days

75 years and older

EXPERIMENTAL

GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older

Drug: GLPG0634 100mg capsule once a day for 10 days

Interventions

GLPG0634 100mg capsule once a day for 10 days DRUG

40-50 years old; 65-74 years old; 75 years and older

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female, age 40 years and older
• BMI between 18-30 kg/m2

You may not qualify if:

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, 2060, Belgium

Location

MeSH Terms

Interventions

GLPG0634

Study Officials

• Frédéric Vanhoutte, MD

  Galapagos NV

  STUDY DIRECTOR

• Magdalena Petkova, MD

  SGS LSS Clinical Pharmacology Unit Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 28, 2013

Record last verified: 2013-03

Locations

BE (1)