Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01665924

GLPG0634-CL-104

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

40-50 years old

Experimental group

Description:

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

Treatment:

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

65-74 years old

Experimental group

Description:

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

Treatment:

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

75 years and older

Experimental group

Description:

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

Treatment:

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