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

Healthy Clinical Trial

Official title:

Open-label Study to Compare the Bioavailability of an Oral Wet Granulation Tablet of GLPG1972 Relative to an Oral Solution and to an Oral Direct Compression Tablet After Single-dose Intake in Healthy Subjects, and to Evaluate the Effect of Food on the Bioavailability of an Oral Wet Granulation Tablet.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143725
• Other study ID #: GLPG1972-CL-105
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2017
• Last updated: June 19, 2017
• Start date: April 14, 2017
• Est. completion date: June 6, 2017

Study information

• Verified date: June 2017
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 6, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Male between 18 and 50 years of age, inclusive,

2. A body mass index (BMI) between 18-30 kg/m², inclusive, weight of at least 50 kg.

3. 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.

4. Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration.

5. Non-smokers and not using any nicotine-containing products.

6. Negative urine drug screen and alcohol breath test.

7. Current sexually active male agrees to use adequate contraception

8. Willing to consume a non-vegetarian high-fat and high-calorie breakfast

9. Able and willing to sign the ICF

Exclusion Criteria:

1. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug

2. 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.

3. History of or a current immunosuppressive condition

4. Symptoms of clinically significant illness in the 3 months before the initial study drug administration.

5. History of malignancy within the past 5 years

6. Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QTcF >450 msec, or a known long QT syndrome).

7. Presence of abnormal liver function

8. Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula.

9. Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.

10. Clinically relevant abnormalities detected on "vital signs"

11. Dietary requirements precluding participation.

12. Significant blood loss including blood donation or had a transfusion of any blood product within 12 weeks

13. Hemoglobin level <7.5 mmol/L (12 g/dL).

14. Active drug or alcohol abuse within 2 years prior to the initial study drug administration.

15. Current (2 weeks before screening) and planned uninterrupted consumption of large quantities (> 6 cups) of coffee

16. Administration of an injectable drug within 30 days prior to the initial study drug administration.

17. Concurrent participation, or participation in a drug/device study within 8 weeks or 5 half-lives of the drug or within 6 months for biologicals

18. Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	SGS Belgium Life Sciences	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	the number of subjects with adverse events	To assess safety and tolerability of GLPG1972 given orally	at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
Secondary	the number of subjects with abnormal vital signs	To assess safety and tolerability of GLPG1972 given orally	at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
Secondary	the number of subjects with abnormal ECG	To assess safety and tolerability of GLPG1972 given orally	at screening, pre-dose at date 1 and post-dose at 24 and 48 hours
Secondary	the number of subjects with abnormal laboratory assessments	To assess safety and tolerability of GLPG1972 given orally	at screening, pre-dose at date 1 and post-dose at 24 and 48 hours