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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01386593
First received: June 29, 2011
Last updated: March 5, 2012
Last verified: March 2012

June 29, 2011
March 5, 2012
May 2011
January 2012   (final data collection date for primary outcome measure)
Area under the plasma concentration versus time curve from timepoint 0 to 24 h (AUC24h) of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
To characterize phenotyping metrics of the "Basel Cocktail" under the condition of inhibition with ciprofloxacin, fluconazole and paroxetine as well as induction with rifampicin. [ Designated as safety issue: No ]

Pharmacokinetic parameters (e.g. Cmax, Tmax, AUC0-24, AUC0-infinity, lambda-z, halflife) will be assessed after administration of the "Basel Cocktail" (a cocktail of 6 different drugs) alone and after inhibition and induction.

The interest is in the width of the change of the pharmacokinetic parameters.

Complete list of historical versions of study NCT01386593 on ClinicalTrials.gov Archive Site
  • Area under the plasma concentration versus time curve from timepoint 0 to infinity (AUC0-inf) of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Peak Time (Tmax) of the "Basel Cocktail" in plasma after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Plasma Halflife (t1/2) in the elimination phase of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Area under the concentration in oral fluid versus time curve from timepoint 0 to 24 h (AUC24h) of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Area under the concentration in oral fluid versus time curve from timepoint 0 to infinity (AUC0-inf) of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Peak Concentration (Cmax) of the "Basel Cocktail" in oral fluid after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Peak Time (Tmax) of the "Basel Cocktail" in oral fluid after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Halflife (t1/2) in the elimination phase of the "Basel Cocktail" in oral fluid after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Area under the concentration in dried blood spots versus time curve from timepoint 0 to 24 h (AUC24h) of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Area under the concentration in dried blood spots versus time curve from timepoint 0 to infinity (AUC0-inf) of the "Basel Cocktail" after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Peak Concentration (Cmax) of the "Basel Cocktail" in dried blood spots after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Peak Time (Tmax) of the "Basel Cocktail" in dried blood spots after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
  • Halflife (t1/2) in the elimination phase of the "Basel Cocktail" in dried blood spots after inhibition with ciprofloxacin, fluconazole and paroxetine and after induction with rifampicin. [ Designated as safety issue: No ]
To evaluate whether alternative matrices such as oral fluid or dried blood spots could also be used for phenotyping under the condition of inhibition and induction. [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pharmacokinetic Study to Characterize Phenotyping Metrics of the "Basel" Cocktail After CYP Induction or Inhibition
Single-center, Randomized, Open-label, Two-way Crossover Study to Characterize Phenotyping Metrics of the "Basel" Cocktail After CYP Induction or Inhibition in Healthy Male Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Metabolic Detoxication, Phase I
  • Drug: Basel cocktail+(Fluconazole, Ciprofloxacin, Paroxetine)
  • Drug: "Basel" Cocktail
  • Drug: Basel cocktail + Rifampicin
  • (A) Baseline
    Intervention: Drug: "Basel" Cocktail
  • (B) Inhibition
    Intervention: Drug: Basel cocktail+(Fluconazole, Ciprofloxacin, Paroxetine)
  • (C) Induction
    Intervention: Drug: Basel cocktail + Rifampicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01386593
EKBB-89/11, 2011 DR 1074
No
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Manuel Haschke, MD University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP