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NCT05891119 · ClinicalTrials.gov registry record · Early Phase 1

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 Early Phase 1 study of Atopic Dermatitis, sponsored by Amgen.

Completed
Registry status
Early Phase 1
Development phase
21
Enrollment target
7
Study locations

NCT05891119 is a Early Phase 1 study of Atopic Dermatitis that has completed, run by Amgen. The registered enrollment target is 21 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT05891119, a Early Phase 1 study of Atopic Dermatitis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Early Phase 1
Development phase
21 participants
Enrollment target
7
Study locations

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 Studied

Interventions

  • DRUG Midazolam
  • DRUG Warfarin
  • DRUG Metoprolol
  • DIETARY_SUPPLEMENT Vitamin K
  • DIETARY_SUPPLEMENT Caffeine

Study Locations (7)

Florida

  • Accel Research Sites (ACR) - DeLand
  • Direct Helpers Research Center (DHRC) - Hialeah

California

  • Velocity Clinical Research, North Hollywood - North Hollywood

Minnesota

  • Axis Clinicals, LCC - Dilworth

Pennsylvania

  • DermDox Dermatology Centers, PC - Camp Hill - Camp Hill

South Carolina

  • Velocity Clinical Research -Spartanburg - Spartanburg

Tennessee

  • DermDox Dermatology Centers, PC - Sugarloaf - Nashville

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2023-06-03
Est. Completion 2025-02-12
Phase Early Phase 1

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT05891119

The ClinicalTrials.gov registry entry for NCT05891119 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (97% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 5 interventions - of which Midazolam is the first listed.

NCT05891119 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Minnesota.

Frequently Asked Questions

What is clinical trial NCT05891119 about?

NCT05891119 is a clinical study titled "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". 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).

What is the current status of trial NCT05891119?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2023-06-03. Estimated completion is 2025-02-12.

What conditions does trial NCT05891119 study?

This clinical trial studies the following conditions: Atopic Dermatitis.

What interventions are being tested in trial NCT05891119?

The interventions under investigation include: Midazolam (DRUG), Warfarin (DRUG), Metoprolol (DRUG), Vitamin K (DIETARY_SUPPLEMENT), Caffeine (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05891119?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05891119 being conducted?

This trial has 7 study locations across California, Florida, Minnesota, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.