Phase
Condition
Obesity
Hypertriglyceridemia
Diabetes Prevention
Treatment
Bupropion
Midazolam
Caffeine
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria :
Otherwise healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 60 years (inclusive) at signing of informed consent
Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) and body weight > 70 kg
Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial, i.e. prior to starting any screening procedures legislation prior to admission to the trial, i.e. prior to starting any screening procedures
Further inclusion criteria apply
Exclusion Criteria :
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and in particular:
Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%,
Aspartate aminotransferase (AST) above ULN + 20%,
Gamma-Glutamyl-Transferase (GGT) above ULN + 20%,
Lipase or amylase above ULN + 20%,
Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m².
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Further exclusion criteria apply
Study Design
Connect with a study center
SGS Life Science Services - Clinical Research
Edegem, 2650
BelgiumSite Not Available
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