A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects

NCT04653467 | Completed Phase 1

• 1 other identifier: GLPG4399-CL-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single (part 1) and multiple ascending (part 2) oral doses of GLPG4399, in adult, healthy, male subjects. In addition, the effect of food and the relative bioavailability (rBA) of GLPG4399, will be evaluated (part 3 and 4).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG4399 in adult, healthy, male subjects.

  From screening through study completion, an average of 6 months

Secondary Outcomes (3)

• Maximum observed plasma concentration (Cmax) of GLPG4399

  Between Day 1 pre-dose and Day 33

• Area under curve (AUC) of GLPG4399

  Between Day 1 pre-dose and Day 33

• Terminal elimination half-life (t1/2) of GLPG4399

  Between Day 1 pre-dose and Day 33

Study Arms (6)

GLPG4399 SAD

EXPERIMENTAL

Single doses of GLPG4399 at up to 6 dose levels in ascending order

Drug: GLPG4399 oral suspension

Placebo SAD

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebo

GLPG4399 MAD

EXPERIMENTAL

Multiple ascending doses of GLPG4399

Drug: GLPG4399 oral suspension

Placebo MAD

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebo

GLPG4399 FE-rBA

EXPERIMENTAL

Single dose of GLPG4399 in fed and fasted state

Drug: GLPG4399 oral suspension; Drug: GLPG4399 capsules

GLPG4399 FE

EXPERIMENTAL

Single dose of GLPG4399 in fed and fasted state

Drug: GLPG4399 oral suspension

Interventions

GLPG4399 oral suspension DRUG

GLPG4399 for oral administration

GLPG4399 FE; GLPG4399 FE-rBA; GLPG4399 MAD; GLPG4399 SAD

GLPG4399 capsules DRUG

GLPG4399 for oral administration

GLPG4399 FE-rBA

Placebo DRUG

Placebo oral suspension

Placebo MAD; Placebo SAD

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
• A body mass index (BMI) between 18.0 and 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, 12-lead ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x 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 not clinically significant in the opinion of the investigator.
• Subject must be able and willing to comply with restrictions on prior and concomitant medication
• Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
• Able and willing to comply with the clinical study protocol (CSP) requirements and to sign and date the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.

You may not qualify if:

• Subject has a history of any drug allergies.
• Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
• 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 IP.
• Subject testing positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected by real-time polymerase chain reaction (RT-PCR) or subjects who have been in contact with SARS-CoV-2 infected individuals in the 2 weeks prior to first dosing of IP. Subjects presenting any signs or symptoms of SARS-CoV-2 infection as detected at screening and/or baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, etc.) will also be excluded. In addition, any other locally applicable standard diagnostic criteria may also apply to diagnose SARS-CoV-2 infection.
• History of or a current immunosuppressive condition (e.g. human immunodeficiency virus (HIV) infection).
• Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.
• Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate (eGFR) \<=90 mL/min/1.73 m2, using the modification of diet in renal disease (MDRD) formula) 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 which is considered cured with minimal risk of recurrence.
• Vital sign abnormalities (systolic blood pressure \<90 or \>140 mmHg, diastolic blood pressure \<60 or \>90 mmHg, or heart rate \<60 or \>100 bpm) at screening.
• History or presence of clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction e.g. known long QT syndrome or a QT interval corrected for heart rate using Fridericia's formula: QTcF = QT/RR1/3 (QTcF) \>450 ms detected on the 12-lead ECG. A first-degree atrioventricular block will not be considered as a significant abnormality.
• Personal or family history of long QT syndrome or unexplained sudden cardiac death in a first-degree relative.
• Male subjects with female partners of child bearing potential not willing to comply with the contraceptive methods
• Significant blood loss (including blood donation \[\>450 mL\]), or transfusion of any blood product within 12 weeks prior to (first) dosing.
• Treatment with any drug known to have a potential for major organ toxicity in the last 3 months before first dosing of the IP.
• Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing of IP.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Altasciences Montreal

Mount Royal, H3P 3E5, Canada

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

Model Details: Part 1: a randomized, double-blind, single ascending dose (SAD), Part 2: a randomized, double-blind, multiple ascending dose (MAD) escalation and Part 3 and 4: an open-label, randomized, crossover rBA and food-effect (FE) part.

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: November 6, 2020
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)