Study to Compare Bioavailability of GLPG1972 Given as 2 Different Tablet Formulations Versus an Oral Solution

NCT03143725 | Completed Phase 1

• 1 other identifier: GLPG1972-CL-105
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet relative to an oral solution and to the oral direct compression (DC) tablet after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the WG oral tablet.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Assessment of the maximum observed plasma concentration of GLPG1972 after single oral doses

  Determine bioavailability of GLPG1972 by assessing PK parameters

  on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses

• Assessment of plasma concentration of GLPG1972 24hrs post-dose after single oral doses

  Determine bioavailability of GLPG1972 by assessing PK parameters

  At 24 hours post dose

• Assessment of time to achieve the maximal plasma concentration of GLPG1972 after single oral doses

  Determine bioavailability of GLPG1972 by assessing PK parameters

  on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses

• Assessment of the last quantifiable plasma concentration of GLPG1972 after single oral doses

  Determine bioavailability of GLPG1972 by assessing PK parameters

  on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses

Secondary Outcomes (4)

• the number of subjects with adverse events

  at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

• the number of subjects with abnormal vital signs

  at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

• the number of subjects with abnormal ECG

  at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

• the number of subjects with abnormal laboratory assessments

  at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

Study Arms (4)

Treatment A

EXPERIMENTAL

GLPG1972 oral solution after overnight fast

Drug: GLPG1972

Treatment B

EXPERIMENTAL

GLPG1972 oral DC tablet after breakfast

Drug: GLPG1972

Treatment C

EXPERIMENTAL

GLPG1972 oral WG tablet after overnight fast

Drug: GLPG1972

Treatment D

EXPERIMENTAL

GLPG1972 oral WG tablet after breakfast

Drug: GLPG1972

Interventions

GLPG1972 DRUG

Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)

Treatment A; Treatment B; Treatment C; Treatment D

Eligibility Criteria

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

You may qualify if:

• Male between 18 and 50 years of age, inclusive,
• A body mass index (BMI) between 18-30 kg/m², inclusive, weight of at least 50 kg.
• Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
• Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration.
• Non-smokers and not using any nicotine-containing products.
• Negative urine drug screen and alcohol breath test.
• Current sexually active male agrees to use adequate contraception
• Willing to consume a non-vegetarian high-fat and high-calorie breakfast
• Able and willing to sign the ICF

You may not qualify if:

• Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
• Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
• History of or a current immunosuppressive condition
• Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
• History of malignancy within the past 5 years
• Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QTcF \>450 msec, or a known long QT syndrome).
• Presence of abnormal liver function
• Renal function with an estimated creatinine clearance \<80 ml/min based on the Cockcroft-Gault formula.
• Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• Clinically relevant abnormalities detected on "vital signs"
• Dietary requirements precluding participation.
• Significant blood loss including blood donation or had a transfusion of any blood product within 12 weeks
• Hemoglobin level \<7.5 mmol/L (12 g/dL).
• Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
• Current (2 weeks before screening) and planned uninterrupted consumption of large quantities (\> 6 cups) of coffee

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS Belgium Life Sciences

Antwerp, Belgium

Location

Study Officials

• Ann Fieuw, MD MSc

  Galapagos NV

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: April 14, 2017
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

BE (1)