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

University Hospital Basel

Status and phase

Completed

Phase 1

Conditions

Metabolic Detoxication, Phase I

Treatments

Drug: Basel cocktail+(Fluconazole, Ciprofloxacin, Paroxetine)

Drug: Basel cocktail + Rifampicin

Drug: "Basel" Cocktail

Study type

Interventional

Funder types

Other

Identifiers

NCT01386593

EKBB-89/11

2011 DR 1074 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess how the pharmacokinetic profiles of each drug of a cocktail of six approved drugs (so-called "Basel cocktail") change when the cytochrome P450 system is inhibited or induced.

Enrollment

16 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.