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.
- Conditions
- Diabetes Type 210018424
- Registration Number
- NL-OMON55090
- Lead Sponsor
- Galapagos NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 57
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 <6.99 mmol/L, fasting defined as no caloric intake for at least
8 hours and hemoglobin A1c (HbA1c) <6.5% (48 mmol/mol). The test should be
performed in a laboratory using a method that is national glycohemoglobin
standardization program (NGSP) certified and standardized to the diabetes
control and complications trial (DCCT) assay. 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.
4. Subject must be able and willing to comply with restrictions on prior
medication as described in Section 6.3.2.
5. Negative screen for drugs (amphetamines, barbiturates, benzodiazepines,
cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
6. Able and willing to comply with the protocol requirements and signing the
informed consent form (ICF) as approved by the Independent Ethics Committee
(IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of single ascending oral doses of<br /><br>GLPG4059, in adult, healthy, male subjects compared with placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the pharmacokinetics (PK) of single ascending oral doses of<br /><br>GLPG4059, in adult, healthy, male subjects.</p><br>