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OpenTrials
Completed

NCT Number: NCT03247699

Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule

Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.

Treatment in period A is the "Basel phenotyping cocktail" capsule. Treatment in period B consists of simultaneous intake of isolated formulations. In both study arms peripheral venous and capillary blood (DBS) samples will be drawn

Completed

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ambulantes Studienzentrum, Universitätsspital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-50 years old
  • Caucasian male volunteers
  • Body mass index (BMI)18-30kg/m2,weight more than 50kg
  • Full mental and legal capacity
  • Signed informed consent prior to any study related procedure
  • Ability to communicate in German or English, sufficient to comprehend and adhere to study protocol
  • Systolic blood pressure (SBP) 100-145mmHg, diastolic blood pressure (DBP) 50-90mmHg and heart rate (HR) 45-90bpm (inclusive), measured on the leading arm*, after 5min in the supine position at screening Normal physical examination, vital signs, laboratory workup, and electrocardiogram (ECG)
  • Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening
  • No other conditions or circumstances that might interfere with compliance with study protocol

Exclusion criteria

  • Known hypersensitivity to any excipients of the drug formulations.
  • 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.
  • History or presence of smoking (within the last 3months prior to screening) or alcohol or drug abuse
  • Intake of prescribed or otc medications, herbal preparations, and / or vitamin/dietary supplements within 2weeks prior to the intended start of study.
  • Excessive caffeine consumption, defined as >800 mg per day at Screening Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450

Treatment and study plan

"Basel phenotyping cocktail" capsule

Other

Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling

"Basel phenotyping cocktail" individual components

Other

Oral intake of "Basel phenotyping cocktail" individual components and PK sampling

Primary outcomes

  1. Concentration-time profile in plasma

    Time frame: -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

    Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios

  2. Concentration-time profile in capillary blood

    Time frame: -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

    Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: CombiCapsIII

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2017
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.