A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects

NCT04856358 | Completed Phase 1

• 2 other identifiers: GLPG3121-CL-1032020-004174-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast. The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.

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-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo

  From screening through study completion, an average of 8 months

Secondary Outcomes (12)

• Maximum observed plasma concentration (Cmax) of GLPG3121 in SAD

  Between Day 1 pre-dose and Day 6

• Cmax of GLPG3121's main metabolite in SAD

  Between Day 1 pre-dose and Day 6

• Cmax of GLPG3121 in MAD

  Between Day 1 pre-dose and Day 19

• Cmax of GLPG3121's main metabolite in MAD

  Between Day 1 pre-dose and Day 19

• Area under the plasma concentration-time curve (AUC) of GLPG3121 in SAD

  Between Day 1 pre-dose and Day 6

Study Arms (6)

GLPG3121 SAD

EXPERIMENTAL

Single doses of GLPG3121 at up to 3 dose levels in ascending order

Drug: GLPG3121

Placebo SAD

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebo

GLPG3121 MAD

EXPERIMENTAL

Multiple doses of GLPG3121 at up to 3 dose levels in ascending order

Drug: GLPG3121

Placebo MAD

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebo

GLPG3121 FE fed

EXPERIMENTAL

Single dose of GLPG3121 in fed state

Drug: GLPG3121

GLPG3121 FE fasted

EXPERIMENTAL

Single dose of GLPG3121 in fasted state

Drug: GLPG3121

Interventions

GLPG3121 DRUG

GLPG3121 modified-release tablet

GLPG3121 FE fasted; GLPG3121 FE fed; GLPG3121 MAD; GLPG3121 SAD

Placebo DRUG

Matching placebo

Placebo MAD; Placebo SAD

Eligibility Criteria

• Age: 18 Years - 55 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 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. Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum creatinine must be no greater than the upper limit of normal (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.

You may not qualify if:

• 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.
• 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 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD) are randomized, double-blind, placebo-controlled; Part 3 Food-effect (FE) is randomized, open-label, crossover

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: April 27, 2021
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: September 19, 2024

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)