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

NCT ID: NCT03143725

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-14
• Study Completion Date: 2017-06-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

GLPG1972 oral solution after overnight fast

Group Type: EXPERIMENTAL

GLPG1972

Intervention Type: DRUG

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

Treatment B

GLPG1972 oral DC tablet after breakfast

Group Type: EXPERIMENTAL

GLPG1972

Intervention Type: DRUG

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

Treatment C

GLPG1972 oral WG tablet after overnight fast

Group Type: EXPERIMENTAL

GLPG1972

Intervention Type: DRUG

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

Treatment D

GLPG1972 oral WG tablet after breakfast

Group Type: EXPERIMENTAL

GLPG1972

Intervention Type: DRUG

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

Interventions

GLPG1972

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Fieuw, MD MSc

Role: STUDY_DIRECTOR

Galapagos NV

Locations

SGS Belgium Life Sciences

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

GLPG1972-CL-105

Identifier Type: -

Identifier Source: org_study_id