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NCT05988021 · ClinicalTrials.gov registry record · Phase 1

A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168

A Phase 1 study of Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target
1
Study location

NCT05988021 is a Phase 1 study of Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis that has completed, run by Amgen. The registered enrollment target is 16 participants, below the 37-participant average among 3 other Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05988021, a Phase 1 study of Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy volunteers.

Interventions

  • DRUG CCX168

Study Locations (1)

Arizona

  • Celerion - Tempe

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2015-12-03
Est. Completion 2016-05-25
Phase Phase 1

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT05988021

The ClinicalTrials.gov registry entry for NCT05988021 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 37-participant average among 3 other Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis trials with a reported enrollment target (57% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis appearing as the primary indexed condition, and to 1 intervention - of which CCX168 is the first listed.

NCT05988021 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT05988021 about?

NCT05988021 is a clinical study titled "A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168". The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy volunteers.

What is the current status of trial NCT05988021?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-12-03. Estimated completion is 2016-05-25.

What conditions does trial NCT05988021 study?

This clinical trial studies the following conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.

What interventions are being tested in trial NCT05988021?

The interventions under investigation include: CCX168 (DRUG).

Who is sponsoring clinical trial NCT05988021?

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

Where is trial NCT05988021 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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