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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifampicin 10 mg QD | Experimental |
| |
| Rifampicin 20 mg QD | Experimental |
| |
| Rifampicin 100 mg QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin treatment | Drug | induction of CYP3A4 with one of three rifampicin doses (10, 20, 100 mg QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 4beta-OHcholesterol | The primary objective of the study is to investigate whether the endogenous cholesterol metabolite 4β-hydroxycholesterol could be used as a marker for induction of CYP3A4. For this purpose the induction of 4β-hydroxycholesterol formation will be compared to the induction of quinine and midazolam metabolism. | Directly before treatment with rifampicin and 14 days after the end of treatment with rifampicin |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio between midazolam AUC induced and midazolam AUC uninduced | Secondary aim of the study is to compare 4β-hydroxycholesterol as a biomarker for CYP3A4 compared to 6β-hydroxycortisol/cortisol ratio, which sometimes is used as a marker for CYP3A4 induction. Another secondary aim is to relate our estimations of CYP3A4-expression to measured levels of 25-OH-vitamin D. | Before treatment with rifampicin and after 14 days of treatment with rifampicin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Bäckström, MD PhD | Department of Clinical Pharmacology, Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Trial Unit (CPTU), Karolinska University Hospital | Stockholm | SE-14186 | Sweden |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |