drugset / Trial / NCT05891119

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

NCT05891119

Phase 0 Completed 21 enrolled Amgen
NaSingle-groupOpen-labelBasic science

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).

Timeline

Start
2023-06-03
Primary completion
2024-08-28
Completion
2025-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Metoprolol Other / unclassified Oral
Subject Midazolam Small molecule Oral
Subject Omeprazole Other / unclassified Oral
Subject Rocatinlimab Monoclonal antibody Subcutaneous
Subject Warfarin Small molecule Oral

Indications