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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: Completed Early Phase 1 study of Atopic Dermatitis, sponsored by Amgen.
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-06-03 |
| Est. Completion | 2025-02-12 |
| Phase | Early Phase 1 |
What the finished NCT05891119 record still lists
NCT05891119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (97% lower).
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 lists 7 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT05891119's enrollment target sits among peer trials
21 134th of 150 higher than 17 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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