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

• Sponsor: Galapagos NV (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03143725
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 4
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GLPG1972	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Apr 14, 2017
• Actual Primary Completion Date: Jun 6, 2017
• Actual Study Completion Date: Jun 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A GLPG1972 oral solution after overnight fast	Drug: GLPG1972; Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
Experimental: Treatment B GLPG1972 oral DC tablet after breakfast	Drug: GLPG1972; Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
Experimental: Treatment C GLPG1972 oral WG tablet after overnight fast	Drug: GLPG1972; Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
Experimental: Treatment D GLPG1972 oral WG tablet after breakfast	Drug: GLPG1972; Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)

Outcome Measures

Primary Outcome Measures

1. Assessment of the maximum observed plasma concentration of GLPG1972 after single oral doses [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]

   Determine bioavailability of GLPG1972 by assessing PK parameters

2. Assessment of plasma concentration of GLPG1972 24hrs post-dose after single oral doses [At 24 hours post dose]

   Determine bioavailability of GLPG1972 by assessing PK parameters

3. Assessment of time to achieve the maximal plasma concentration of GLPG1972 after single oral doses [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]

   Determine bioavailability of GLPG1972 by assessing PK parameters

4. Assessment of the last quantifiable plasma concentration of GLPG1972 after single oral doses [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]

   Determine bioavailability of GLPG1972 by assessing PK parameters

Secondary Outcome Measures

1. the number of subjects with adverse events [at screening, pre-dose at date 1 and post-dose at 24 and 48 hours]

   To assess safety and tolerability of GLPG1972 given orally

2. the number of subjects with abnormal vital signs [at screening, pre-dose at date 1 and post-dose at 24 and 48 hours]

   To assess safety and tolerability of GLPG1972 given orally

3. the number of subjects with abnormal ECG [at screening, pre-dose at date 1 and post-dose at 24 and 48 hours]

   To assess safety and tolerability of GLPG1972 given orally

4. the number of subjects with abnormal laboratory assessments [at screening, pre-dose at date 1 and post-dose at 24 and 48 hours]

   To assess safety and tolerability of GLPG1972 given orally

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SGS Belgium Life Sciences	Antwerp		Belgium

Sponsors and Collaborators

• Galapagos NV

Investigators

• Study Director: Ann Fieuw, MD MSc, Galapagos NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galapagos NV
• ClinicalTrials.gov Identifier: NCT03143725
• Other Study ID Numbers: GLPG1972-CL-105
• First Posted: May 8, 2017
• Last Update Posted: Jun 20, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 20, 2017