First-in-Human Single and Multiple Dose of GLPG2222

NCT02662452 | Completed Phase 1

• 2 other identifiers: GLPG2222-CL-1012015-004466-29
• Study Type: interventional
• Target: 40
• 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 GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2). Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Change versus placebo in number of subjects with adverse events

  To evaluate the safety and tolerability of GLPG2222 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 GLPG2222 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 GLPG2222 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram

  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 GLPG2222 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

• Change versus placebo in number of subjects with abnormal pulmonary function

  To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry

  Between screening and 4 days after the last dose (Part 1 only)

Secondary Outcomes (3)

• The amount of GLPG2222 in plasma

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

• The amount of GLPG2222 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

Study Arms (4)

GLPG2222 single dose

EXPERIMENTAL

Single dose of GLPG2222 oral suspension

Drug: GLPG2222 single dose

Placebo single dose

PLACEBO COMPARATOR

Single dose of placebo oral suspension

Drug: Placebo single dose

GLPG2222 multiple doses

EXPERIMENTAL

Multiple doses of GLPG2222 oral suspension

Drug: GLPG2222 multiple doses

Placebo multiple doses

PLACEBO COMPARATOR

Multiple doses of placebo oral suspension

Drug: Placebo multiple doses

Interventions

GLPG2222 single dose DRUG

single ascending doses, oral suspension

GLPG2222 single dose

Placebo single dose DRUG

single doses, oral suspension, matching placebo

Placebo single dose

GLPG2222 multiple doses DRUG

multiple ascending doses, daily for 14 days, oral suspension

GLPG2222 multiple doses

Placebo multiple doses DRUG

multiple doses, daily for 14 days, oral suspension, matching placebo

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
• Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)

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 or biologic 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 must be used

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Location

MeSH Terms

Interventions

GLPG2222

Study Officials

• Kirsteen Donaldson, 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: January 20, 2016
• First Posted: January 25, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)