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NCT01290042 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.

A Phase 1 study of Ulcerative Colitis and Crohn's Disease, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
43
Enrollment target
8
Study locations

NCT01290042 is a Phase 1 study of Ulcerative Colitis and Crohn's Disease that has completed, run by Amgen. The registered enrollment target is 43 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT01290042, a Phase 1 study of Ulcerative Colitis and Crohn's Disease, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
43 participants
Enrollment target
8
Study locations

Study Summary

To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Conditions Studied

Ulcerative Colitis Crohn's Disease

Interventions

  • DRUG AMG 181
  • OTHER Placebo for AMG 181

Study Locations (8)

Connecticut

  • Research Site - Bridgeport
  • Research Site - Danbury

California

  • Research Site - Glendale

Florida

  • Research Site - Miami

Pennsylvania

  • Research Site - Duncansville

Queensland

  • Research Site - Herston

South Australia

  • Research Site - Adelaide

Victoria

  • Research Site - Prahran

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2011-02
Est. Completion 2014-05
Phase Phase 1

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT01290042

The ClinicalTrials.gov registry entry for NCT01290042 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which AMG 181 is the first listed.

NCT01290042 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Connecticut, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01290042 about?

NCT01290042 is a clinical study titled "Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.". To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

What is the current status of trial NCT01290042?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2011-02. Estimated completion is 2014-05.

What conditions does trial NCT01290042 study?

This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease.

What interventions are being tested in trial NCT01290042?

The interventions under investigation include: AMG 181 (DRUG), Placebo for AMG 181 (OTHER).

Who is sponsoring clinical trial NCT01290042?

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

Where is trial NCT01290042 being conducted?

This trial has 8 study locations across California, Connecticut, Florida, Pennsylvania, Queensland. 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

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.