Trials / Completed
CompletedNCT04562116
A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis
An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Subjects With Moderate-to-Severe Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderate to- severe atopic dermatitis (AD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nemolizumab | Nemolizumab 30 mg will be administered as SC injections. |
| DRUG | CYP 450 Substrates | CYP substrates (Caffeine, Warfarin Sodium, Midazolam, Omeprazole, and Metoprolol Tartrate) will administered orally at Week 0 (Day 1) and Week 10 as per the commercially available prescribing information. |
Timeline
- Start date
- 2021-12-08
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
- First posted
- 2020-09-24
- Last updated
- 2024-12-05
- Results posted
- 2024-12-05
Locations
6 sites across 2 countries: United States, Bulgaria
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04562116. Inclusion in this directory is not an endorsement.