First-in-Human Single and Multiple Dose of GLPG1972

NCT02612246 | Completed Phase 1

• 2 other identifiers: GLPG1972-CL-1012015-004156-21
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 given to healthy subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well. During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Change versus placebo in number of subjects with adverse events

  To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events

  Between screening and 7-10 days after the last dose

• Change versus placebo in number of subjects with abnormal laboratory parameters

  To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters

  Between screening and 7-10 days after the last dose

• Change versus placebo in number of subjects with abnormal vital signs

  To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs

  Between screening and 7-10 days after the last dose

• Change versus placebo in number of subjects with abnormal electrocardiogram

  To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms

  Between screening and 7-10 days after the last dose

• Change versus placebo in number of subjects with abnormal physical examination

  To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination

  Between screening and 7-10 days after the last dose

Secondary Outcomes (4)

• The amount of GLPG1972 in plasma

  Between Day 1 predose and 48 hours after the (last) dose

• The amount of GLPG1972 in urine

  Between Day 1 predose and 24 hours after the (last) dose

• Ratio of 6-b-hydroxycortisol/cortisol in urine

  Twelve hours before dosing on Day 1 and Day 14

• Levels of GLPG1972 biomarker in blood

  Between Day 1 predose and 48 hours after the last dose

Study Arms (4)

GLPG1972 single dose

EXPERIMENTAL

Single oral dose of GLPG1972 solution - ascending doses

Drug: GLPG1972 single ascending doses

Placebo single dose

PLACEBO COMPARATOR

Single oral dose of placebo solution

Drug: Placebo single dose

GLPG1972 multiple doses

EXPERIMENTAL

Multiple oral doses of GLPG1972 solution - ascending doses

Drug: GLPG1972 multiple ascending doses

Placebo multiple doses

PLACEBO COMPARATOR

Multiple oral doses of placebo solution

Drug: Placebo multiple doses

Interventions

GLPG1972 single ascending doses DRUG

single dose, oral solution

GLPG1972 single dose

Placebo single dose DRUG

single dose, oral solution, matching placebo

Placebo single dose

GLPG1972 multiple ascending doses DRUG

multiple doses, daily for 14 days, oral solution

GLPG1972 multiple doses

Placebo multiple doses DRUG

multiple doses, daily for 14 days, oral solution

Placebo multiple doses

Eligibility Criteria

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

You may qualify if:

• Males between 18-50 years of age
• Subjects must have a body mass index between 18-30 kg/m²
• Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile

You may not qualify if:

• A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
• Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device investigational research study
• A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
• Current sexually active (and/or child wish) male; a contraception method should be used

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Location

Study Officials

• Ennis Lee, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-03

Locations

BE (1)