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

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ClinicalTrials.gov Identifier: NCT03899909
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG3121 SAD Drug: Placebo SAD Drug: GLPG3121 MAD Drug: Placebo MAD Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A First-in-human, Randomized, Double-blind, Placebo-controlled, Single Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3121 for 13 Days in Adult, Healthy, Male Subjects.
Actual Study Start Date : March 29, 2019
Actual Primary Completion Date : June 3, 2019
Actual Study Completion Date : June 3, 2019

Arm Intervention/treatment
Experimental: GLPG3121 SAD
Single doses of GLPG3121 at up to 6 dose levels in ascending order
Drug: GLPG3121 SAD
GLPG3121 oral suspension, single ascending doses

Placebo Comparator: Placebo SAD
Single doses of placebo
Drug: Placebo SAD
Placebo oral suspension

Experimental: GLPG3121 MAD
Multiple doses of GLPG3121 at up to 4 dose levels in ascending order
Drug: GLPG3121 MAD
GLPG3121 oral suspension, multiple ascending doses, daily for 13 days

Placebo Comparator: Placebo MAD
Multiple doses of placebo
Drug: Placebo MAD
Placebo oral suspension, daily for 13 days




Primary Outcome Measures :
  1. Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations. [ Time Frame: 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 :
  1. Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL) [ Time Frame: 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

  2. Area under curve (AUC) of GLPG3121 (μg.h/mL) [ Time Frame: 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

  3. Terminal elimination half-life (t1/2) of GLPG3121 (h) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899909


Locations
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Belgium
SGS Belgium NV - Clinical Pharmacology Unit Antwerp
Antwerp, Belgium, 2060
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Magdalena Petkova, MD Galapagos NV

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03899909     History of Changes
Other Study ID Numbers: GLPG3121-CL-101
2018-002174-40 ( EudraCT Number )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No