NL-OMON46290
Completed
Not Applicable
An open-label, multi-centre drug-drug interaction trial to investigate the effects of tralokinumab on the pharmacokinetics of selected cytochrome P450 (CYP) substrates in adult subjects with moderate-to-severe atopic dermatitis - Drug-drug interaction tralokinumab in moderate-to-severe atopic dermatitis
eo Pharma0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eo Pharma
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Age 18 and above.
- •\* Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- •\* History of AD for \*1 year.
- •\* Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
- •\* AD involvement of \*10% body surface area at screening and baseline.
- •\* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
- •\* Willingness to abstain from consumption of any 1 or more of the following items in the periods specified:
- •o ±7 days within each cocktail dosing visit (that is, between the Day \-14 and Day 15 visits and between the Week 14 and Week 16 visits): foods/beverages that affect the CYP system:
- •\- Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
- •\- Cruciferous vegetables, including but not limited to broccoli, cabbage, cauliflower, kale, Brussels sprout, radish, turnip, horseradish.
Exclusion Criteria
- •\* Administration, within 14 days or 5 half\-lives (whichever is longer) prior to Day \-7, of any medication that is a known inducer or inhibitor of 1 or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2\.
- •\* Subjects who are poor metabolisers of CYP2C9, CYP2C19, or CYP2D6, based on genotyping.
- •\* Any contraindication to 1 or more of the following drugs, according to the applicable labelling: caffeine, warfarin, omeprazole, metoprolol, or midazolam.
- •\* Consumption of any 1 or more of the following items in the periods specified:
- •o From Day \-14 (±7 days within each cocktail dosing visit):
- •foods/beverages that affect the CYP system:
- •\- Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
- •\- Cruciferous vegetables, including but not limited to broccoli, cabbage, cauliflower, kale, Brussels sprout, radish, turnip, horseradish.
- •\- Chargrilled meat.
- •o From Day \-9 (±48 hours within each cocktail dosing visit):
Outcomes
Primary Outcomes
Not specified
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