Pharmacokinetic Study to Characterize Phenotyping Metrics of the "Basel" Cocktail After CYP Induction or Inhibition

Inclusion criteria

• Male aged between 18 and 35 years (inclusive) at screening.
• No clinically significant findings on the physical examination at screening.
• Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) and body weight at least 50 kg at screening.
• Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg and heart rate (HR) 45-90 bpm (inclusive).
• 12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
• Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.
• Ability to communicate well with the investigator and to understand and comply with the requirements of the study.

Exclusion criteria

• Known hypersensitivity to any excipients of the drug formulations.
• Treatment with another investigational drug within 30 days prior to screening.
• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
• Positive results from urine drug screen at screening.
• Excessive caffeine consumption, defined as >800 mg per day at screening*.
• African or Hispanic ethnicity.
• History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
• Smoking within the last 3 months prior to screening.
• Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to the intended start of study.
• Loss of 250 ml or more of blood within 3 months prior to screening.
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
• Legal incapacity or limited legal capacity at screening.