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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097938
• Other study ID #: GLPG3667-CL-101
• Secondary ID: 2019-001659-38
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2019
• Est. completion date: July 6, 2020

Study information

• Verified date: July 2020
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 6, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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-a) 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG3667 oral suspension
GLPG3667 oral suspension
• Placebos
Placebo oral suspension
• GLPG3667 capsules
GLPG3667 capsules

Locations

Country	Name	City	State
Belgium	SGS Belgium NV - Clinical Pharmacology Unit Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 GLPG3667, in adult, healthy, male subjects compared with placebo	From screening through study completion, an average of 5 months
Secondary	Maximum observed plasma concentration (Cmax) of GLPG3667 (µg/mL)	To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects	Between Day 1 pre-dose and Day 16
Secondary	Area under curve (AUC) of GLPG3667 (µg.h/mL)	To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects	Between Day 1 pre-dose and Day 16
Secondary	Terminal elimination half-life (t1/2) of GLPG3667 (h)	To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects	Between Day 1 pre-dose and Day 16