Study to Assess Bioavailability of GLPG1690 Given as Oral Capsule or Tablet

Healthy Clinical Trial

Official title:

An Open Label Study to Compare the Oral Bioavailability of a Tablet of GLPG1690 Relative to a Capsule After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143712
• Other study ID #: GLPG1690-CL-103
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2017
• Last updated: June 19, 2017
• Start date: April 18, 2017
• Est. completion date: June 14, 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 three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 14, 2017
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

2. Body mass index (BMI) between 18-30 kg/m2, inclusive, with a 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/preventive exposure measures from the time of first dose of study drug, during the study and until 12 weeks after the last study drug dose.

8. Subjects should be willing to consume the 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. Presence of abnormal liver function. Diagnosis of disease of Gilbert is accepted. Retesting is allowed.

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

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

7. History of malignancy within the past 5 years

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

9. Clinically relevant abnormalities detected on vital signs.

10. Dietary requirements precluding participation in the study

11. Significant blood loss (including blood donation [=450 mL]), or transfusion of any blood product within 8 weeks prior to the signing of ICF.

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

13. Consumption of large quantities of caffeinated coffee or tea (>6 cups/day), or equivalent.

14. Concurrent participation or participation in a drug or drug/device investigational research study.

15. Subjects who participated in a previous study with the same compound (GLPG1690).

16. Investigator or any sub-investigator, or other staff or relative.

17. Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG1690
Oral administration of GLPG1690 in three different treatment conditions (treatment A through C)

Locations

Country	Name	City	State
Belgium	SGS CPU	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 GLPG1690 after single oral doses	Determine the bioavailability of GLPG1690 by assessing PK parameters	predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Primary	Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses	Determine the bioavialability of GLPG1690 by assessing PK parameters	predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Primary	Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses	Determine the bioavialability of GLPG1690 by assessing PK parameters	predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Secondary	The number of subjects with adverse events	To assess safety and tolerability of GLPG1690	Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
Secondary	The number of subjects with abnormal vital signs	To assess safety and tolerability of GLPG1690	Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
Secondary	The number of subjects with abnormal ECG	To assess safety and tolerability of GLPG1690	Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
Secondary	The number of subjects with abnormal physical examination	To assess safety and tolerability of GLPG1690	Throughout the study from screening until the follow up visit (day 7 of dosing period 3)
Secondary	The number of subjects with abnormal laboratory analysis	To assess safety and tolerability of GLPG1690	Throughout the study from screening until the follow up visit (day 7 of dosing period 3)