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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 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-12-23

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-03
Primary Completion
2024-08-28
Completion
2025-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05891119 on ClinicalTrials.gov