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

NCT ID: NCT01386593

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-01-31

Brief Summary

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.

Conditions

Metabolic Detoxication, Phase I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

(A) Baseline

Group Type: OTHER

"Basel" Cocktail

Intervention Type: DRUG

(B) Inhibition

Group Type: OTHER

Basel cocktail+(Fluconazole, Ciprofloxacin, Paroxetine)

Intervention Type: DRUG

(C) Induction

Group Type: OTHER

Basel cocktail + Rifampicin

Intervention Type: DRUG

Interventions

Basel cocktail+(Fluconazole, Ciprofloxacin, Paroxetine)

Intervention Type: DRUG

"Basel" Cocktail

Intervention Type: DRUG

Basel cocktail + Rifampicin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Haschke, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Phase I Research Unit, University Hospital

Basel, , Switzerland

Countries

Switzerland

References

Derungs A, Donzelli M, Berger B, Noppen C, Krahenbuhl S, Haschke M. Effects of Cytochrome P450 Inhibition and Induction on the Phenotyping Metrics of the Basel Cocktail: A Randomized Crossover Study. Clin Pharmacokinet. 2016 Jan;55(1):79-91. doi: 10.1007/s40262-015-0294-y.

Reference Type: DERIVED

PMID: 26123704 (View on PubMed)

Other Identifiers

2011 DR 1074

Identifier Type: OTHER

Identifier Source: secondary_id

EKBB-89/11

Identifier Type: -

Identifier Source: org_study_id