Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097938
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 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, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG3667 Drug: Placebos Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3667 in Adult, Healthy, Male Subjects
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: GLPG3667 SAD
Single doses of GLPG3667 at up to 6 dose levels in ascending order
Drug: GLPG3667
GLPG3667 oral suspension

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

Experimental: GLPG3667 MAD
Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days
Drug: GLPG3667
GLPG3667 oral suspension

Placebo Comparator: Placebo MAD
Multiple doses of placebo
Drug: Placebos
Placebo oral suspension




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 5 months ]
    To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of GLPG3667 (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 GLPG3667, in adult, healthy, male subjects

  2. Area under curve (AUC) of GLPG3667 (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 GLPG3667, in adult, healthy, male subjects

  3. Terminal elimination half-life (t1/2) of GLPG3667 (h) [ Time Frame: Between Day 1 pre-dose and Day 16 ]
    To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF)
  • A body mass index (BMI) between 18-30 kg/m2, inclusive
  • Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. 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 not clinically 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-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part)
  • Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.

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): NCT04097938


Contacts
Layout table for location contacts
Contact: Galapagos Medical Information +32 15 34 29 00 medicalinfo@glpg.com

Locations
Layout table for location information
Belgium
SGS Belgium NV - Clinical Pharmacology Unit Antwerp Recruiting
Antwerp, Belgium, 2060
Sponsors and Collaborators
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Magdalena Petkova, MD Galapagos NV

Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT04097938     History of Changes
Other Study ID Numbers: GLPG3667-CL-101
2019-001659-38 ( EudraCT Number )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No