A first-in-human, randomized, double-blind, placebo-controlled, study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of GLPG4059 in adult, healthy, male subjects.

A first-in-human, randomized, double-blind, placebo-controlled, study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of GLPG4059 in adult, healthy, male subjects. - GLPG4059 single ascending dose study to investigate safety and PK

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55090

Enrollment

Registered

2020-04-21

Start date

2020-09-01

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

Interventions

Part 1: Volunteer will receive a single dose of the study compound in the morning of Day 1 orally as a liquid (between 0.15 and 15 milliliters. The study compound will be administered via a syringe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male between 18-54 years of age 2. A BMI) between 18.0-30.0 kg/m2, inclusive. 3. 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. ECG and vital signs parameters must be within the normal ranges as described in Appendix 1. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x ULN. Fasting plasma glucose must be

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator. 2. 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. For the complete overview see the protocol.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single ascending oral doses of GLPG4059, in adult, healthy, male subjects compared with placebo.	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG4059, in adult, healthy, male subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)