Trials / Completed
CompletedNCT03556592
Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4
An Open-label, Multi Centre Drug-drug Interaction Trial to Investigate the Effects of Tralokinumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Subjects With Moderate-to-severe Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- LEO Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after: * 14 weeks of treatment with tralokinumab * a single dose of tralokinumab
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tralokinumab | Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection. |
| DRUG | Caffeine | 1x 100 mg tablet |
| DRUG | Warfarin | 2x 5 mg tablets |
| DRUG | Omeprazole | 1x 20 mg capsule |
| DRUG | Metoprolol | 1x 100 mg tablet |
| DRUG | Midazolam Hydrochloride | 1 mL of 2 mg/mL oral solution/syrup |
Timeline
- Start date
- 2018-08-13
- Primary completion
- 2020-03-16
- Completion
- 2020-06-20
- First posted
- 2018-06-14
- Last updated
- 2025-02-24
Locations
12 sites across 3 countries: United States, France, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03556592. Inclusion in this directory is not an endorsement.