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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebos; Drug: GLPG3667 capsules; Drug: GLPG3667 oral suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT04097938

GLPG3667-CL-101

2019-001659-38 (EudraCT Number)

Details and patient eligibility

About

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 (PK) 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. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

Enrollment: 52 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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52 participants in 9 patient groups, including a placebo group

GLPG3667 SAD

Experimental group

Description:

Single doses of GLPG3667 at up to 6 dose levels in ascending order

Treatment:

Drug: GLPG3667 oral suspension

Placebo SAD

Placebo Comparator group

Description:

Single doses of placebo

Treatment:

Drug: Placebos

GLPG3667 MAD

Experimental group

Description:

Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days

Treatment:

Drug: GLPG3667 oral suspension

Placebo MAD

Placebo Comparator group

Description:

Multiple doses of placebo

Treatment:

Drug: Placebos

GLPG3667 FE fasted

Experimental group

Description:

Single dose of GLPG3667 in fasted state

Treatment:

Drug: GLPG3667 oral suspension

GLPG3667 FE fed

Experimental group

Description:

Single dose of GLPG3667 in fed state

Treatment:

Drug: GLPG3667 oral suspension

GLPG3667 oral suspension rBA-FE fed

Experimental group

Description:

Single dose of GLPG3667 oral suspension in fed state

Treatment:

Drug: GLPG3667 oral suspension

GLPG3667 capsules rBA-FE fasted

Experimental group

Description:

Single dose of GLPG3667 capsules in fasted state

Treatment:

Drug: GLPG3667 capsules

GLPG3667 capsules rBA-FE fed

Experimental group

Description:

Single dose of GLPG3667 capsules in fed state

Treatment:

Drug: GLPG3667 capsules