This is a Study to Evaluate the Effect of Aging of Multiple Doses of GLPG1205 in Healthy Subjects

NCT03102567 | Completed Phase 1

• 1 other identifier: GLPG1205-CL-105
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of GLPG1205 in healthy male subjects. The study will comprise of 2 parts, a first part to investigate the effect of aging and a second part to investigate the effect of a loading dose.

Conditions

Healthy; Elderly

Outcome Measures

Primary Outcomes (13)

• Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events

  to assess safety and tolerability in the first placebo controlled part of the study

  From screening until the final follow up visit (day 35)

• Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations

  to assess safety and tolerability in the first placebo controlled part of the study

  From screening until the final follow up visit (day 35)

• Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs

  to assess safety and tolerability in the first placebo controlled part of the study

  From screening until the final follow up visit (day 35)

• Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG

  to assess safety and tolerability in the first placebo controlled part of the study

  From screening until the final follow up visit (day 35)

• Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination

  to assess safety and tolerability in the first placebo controlled part of the study

  From screening until the final follow up visit (day 35)

• Difference between healthy male subjects of different age groups of Cmax of GLPG1205

  To assess PK of GLPG1205 in the first part of the study with different age groups

  From day 1 pre-dose until the final follow up visit (day 35)

• Difference between healthy male subjects of different age groups of tmax of GLPG1205

  To assess PK of GLPG1205 in the first part of the study with different age groups

  From day 1 pre-dose until the final follow up visit (day 35)

• Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205

  To assess PK of GLPG1205 in the first part of the study with different age groups

  From day 1 pre-dose until the final follow up visit (day 35)

• Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205

  To assess PK of GLPG1205 in the first part of the study with different age groups

  From day 1 pre-dose until the final follow up visit (day 35)

• Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose

  In the open label (part 2) of the study

  From day 1 pre-dose until the final follow up visit (day 35)

• Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose

  In the open label (part 2) of the study

  From day 1 pre-dose until the final follow up visit (day 35)

• Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose

  In the open label (part 2) of the study

  From day 1 pre-dose until the final follow up visit (day 35)

• Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose

  In the open label (part 2) of the study

  From day 1 pre-dose until the final follow up visit (day 35)

Secondary Outcomes (1)

• Assessment of creatinine clearance in healthy elderly subjects

  From screening until the final follow up visit (day 35)

Study Arms (3)

GLPG1205 50mg q.d.

EXPERIMENTAL

oral hard gelatin capsules with 50 mg GLPG1205 for q.d. administration - compared to placebo

Drug: GLPG1205 50mg q.d.

placebo

PLACEBO COMPARATOR

oral hard gelatin capsules containing placebo for q.d. administration

Drug: Placebo oral capsule

GLPG1205 250 mg loading and 50mg q.d. maintenance

EXPERIMENTAL

open label - oral hard gelatin capsules with 50 mg GLPG1205 for one time 250 mg loading dose and subsequent 50mg q.d. administration

Drug: GLPG1205 250 loading dose and 50mg q.d. maintenance dose

Interventions

GLPG1205 50mg q.d. DRUG

oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo

GLPG1205 50mg q.d.

Placebo oral capsule DRUG

oral gelatin capsule containing placebo to match study arm 1 - q.d. administration

placebo

GLPG1205 250 loading dose and 50mg q.d. maintenance dose DRUG

Open label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration

GLPG1205 250 mg loading and 50mg q.d. maintenance

Eligibility Criteria

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

You may qualify if:

• Male, aged over 18 years
• Able and willing to sign the ICF.
• Able and willing to comply with the requirements of the study.
• Body Mass Index (BMI) between 18 and 30 kg/m² inclusive.
• Weight between 60 and 90 kg, inclusive (Cohort A only).
• Considered by the Investigator to be in good health.
• Discontinuation of all medications with the exception of occasional paracetamol
• Have a creatinine clearance (estimated by Cockroft-Gault equation) \> 80 mL/min for subjects aged up to 50 years in cohort C and \> 60 mL/min for subjects of 65 years and over in cohorts A, B and D.
• A non-smoker and not using any nicotine-containing products .
• Negative tests for drug screen, alcohol screen, and cotinine screen.
• Male subjects and their female partners of child-bearing potential must agree to use a highly effective method of contraception.

You may not qualify if:

• Known hypersensitivity to GLPG1205 or excipients of the formulation. A history of significant allergic reaction to any drug, such as anaphylaxis requiring hospitalization.
• Positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Clinically significant illness in the 12 weeks prior to study screening.
• Current or sequelae of gastrointestinal, liver or kidney disease or any other condition that might interfere with absorption, distribution, metabolism or excretion of drugs.
• History of malignancy in the last 5 years.
• Clinically significant abnormalities on ECG of rhythm or conduction
• Clinically significant abnormalities detected on physical examination or vital signs.
• Clinically significant abnormalities detected on laboratory safety testing
• Significant blood loss, including blood donation of \> 450 mL, or receiving a blood transfusion or blood product in the 12 weeks prior to study screening.
• Active drug or alcohol abuse within 2 years prior to study screening.
• Consumption of large quantities of caffeinated coffee or tea (\> 6 cups/day), or equivalent. The consumption of alcohol, methyl-xanthine-containing beverages or foods (e.g., coffee, tea cocoa, cola and chocolate), quinine (e.g., tonic water), grapefruit or grapefruit juice, Seville oranges and poppy seeds within 48 h of study medication administration until the end of the dosing period.
• Concurrent or recent participation in an investigational medicinal research study.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS clinical pharmacology unit

Antwerp, Belgium

Location

MeSH Terms

Interventions

GLPG1205

Study Officials

• Helen Timis, MBChB MICR

  Galapagos NV

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 5, 2017
• Study Start: October 18, 2016
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-03

Locations

BE (1)