CYP450 Phenotyping Clinical Trial
— CombiCapsIIIOfficial title:
Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
| Verified date | September 2017 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | July 30, 2017 |
| Est. primary completion date | July 1, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Ambulantes Studienzentrum, Universitätsspital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Concentration-time profile in plasma | Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios | -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 | |
| Primary | Concentration-time profile in capillary blood | Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios | -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 |