A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects

NCT03899909 | Completed Phase 1

• 2 other identifiers: GLPG3121-CL-1012018-002174-40
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations.

  To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo.

  From screening through study completion, an average of 6 months.

Secondary Outcomes (3)

• Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL)

  Between Day 1 pre-dose and Day 16

• Area under curve (AUC) of GLPG3121 (μg.h/mL)

  Between Day 1 pre-dose and Day 16

• Terminal elimination half-life (t1/2) of GLPG3121 (h)

  Between Day 1 pre-dose and Day 16

Study Arms (4)

GLPG3121 SAD

EXPERIMENTAL

Single doses of GLPG3121 at up to 6 dose levels in ascending order

Drug: GLPG3121 SAD

Placebo SAD

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebo SAD

GLPG3121 MAD

EXPERIMENTAL

Multiple doses of GLPG3121 at up to 4 dose levels in ascending order

Drug: GLPG3121 MAD

Placebo MAD

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebo MAD

Interventions

GLPG3121 SAD DRUG

GLPG3121 oral suspension, single ascending doses

GLPG3121 SAD

Placebo SAD DRUG

Placebo oral suspension

Placebo SAD

GLPG3121 MAD DRUG

GLPG3121 oral suspension, multiple ascending doses, daily for 13 days

GLPG3121 MAD

Placebo MAD DRUG

Placebo oral suspension, daily for 13 days

Placebo MAD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
• Male between 18 to 55 years of age (extremes included), on the date of signing the ICF.
• A Body Mass Index (BMI) between 18.0 to 30.0 kg/m2, inclusive.
• Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, (triplicate) 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x the upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered nonclinically significant in the opinion of the investigator.

You may not qualify if:

• Known hypersensitivity to investigational medicinal product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
• Known contraindication or hypersensitivity to interferon-α (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part).
• Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP.
• Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min a 24-hours urine collection to assess creatinine clearance can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, 2060, Belgium

Location

Study Officials

• Magdalena Petkova, 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: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 2, 2019
• Study Start: March 29, 2019
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)