Trials / Completed
CompletedNCT05891119
Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis
A Phase 1, Open-label, Drug-Drug Interaction Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple CYP450 Substrates in Patients With Moderate to Severe Atopic Dermatitis
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the pharmacokinetics (PK) of multiple cytochrome P450 (CYP450) substrates alone and in combination with rocatinlimab in participants with moderate to severe atopic dermatitis (AD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Caffeine | Oral liquid |
| DRUG | Metoprolol | Oral tablet |
| DRUG | Midazolam | Oral liquid |
| DRUG | Warfarin | Oral tablet |
| DIETARY_SUPPLEMENT | Vitamin K | Oral tablet |
| DRUG | Omeprazole | Oral capsule |
| DRUG | Rocatinlimab | Subcutaneous injection |
Timeline
- Start date
- 2023-06-03
- Primary completion
- 2024-08-28
- Completion
- 2025-02-12
- First posted
- 2023-06-06
- Last updated
- 2025-12-23
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05891119. Inclusion in this directory is not an endorsement.