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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo SAD; Drug: GLPG3121 SAD; Drug: GLPG3121 MAD; Drug: Placebo MAD

• Registration Number: NCT03899909
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-29
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Primary Completion: 2019-06-03
• Study Completion: 2019-06-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo SAD	Placebo SAD	Single doses of placebo
GLPG3121 SAD	GLPG3121 SAD	Single doses of GLPG3121 at up to 6 dose levels in ascending order
GLPG3121 MAD	GLPG3121 MAD	Multiple doses of GLPG3121 at up to 4 dose levels in ascending order
Placebo MAD	Placebo MAD	Multiple doses of placebo

Primary Outcome Measures

Name	Time	Method
Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations.	From screening through study completion, an average of 6 months.	To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo.

Secondary Outcome Measures

Name	Time	Method
Area under curve (AUC) of GLPG3121 (μg.h/mL)	Between Day 1 pre-dose and Day 16	To evaluate the PK of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects
Terminal elimination half-life (t1/2) of GLPG3121 (h)	Between Day 1 pre-dose and Day 16	To evaluate the PK of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects
Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL)	Between Day 1 pre-dose and Day 16	To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects

Trial Locations

Locations (1)

SGS Belgium NV - Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium