Loading clinical trials...

A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants

A Multiple-dose, Randomized, Double-blind, Placebo-controlled, Active-Comparator, Parallel Study to Investigate the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Subjects

NCT05988034•Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the effects of therapeutic and supratherapeutic doses of avacopan on the heart rate corrected QT interval, using Fridericia's formula (QTcF).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Be able to verbalize understanding of consent form and able to provide written informed consent;
•Healthy male or female: No known history of a clinically significant medical diagnosis in the opinion of the Investigator and is not receiving prescription medication except birth control therapies; this includes but is not limited to no history of heart or lung disease (including latent tuberculosis), high blood pressure, history of any cardiac or endocrine disease (including thyroid disease and diabetes); appendectomy and cholecystectomy are allowed;
•Aged ≥18 and ≤60 years at the time of screening;
•Body mass index ≥18.0 and ≤30.0 kg/m\^2, and body weight of ≥50 kg, at screening and Day -2;
•Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration;
•Willing to communicate with an investigator and site staff and comply with all study procedures and requirements.

Exclusion Criteria

•An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval \>110 msec; QTcF \>450 msec; PR interval \>200 msec; HR \<40 bpm; or any rhythm other than sinus rhythm that is interpreted an investigator to be clinically significant;
•History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia. Participants will also be excluded if there is a family history of long QT syndrome or Brugada syndrome;
•A sustained supine systolic blood pressure \>150 mm Hg or \<90 mm Hg or a supine diastolic blood pressure \>95 mm Hg or \<50 mm Hg at screening or on Day -1. Blood pressure may be retested more than once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 3 assessments and the participant may not be randomized;
•A resting HR of \<40 bpm or \>100 bpm when vital signs are measured at screening or on Day -1;
•Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia;
•History of acquired immunodeficiency syndrome or positive test results for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B surface antigen at screening;
•Positive urine drug or alcohol screen at screening or on Day -2 (admission);
•Clinically significant illness, including viral syndromes within 3 weeks prior to Day 1;
•Women who are pregnant according to a serum pregnancy test (or planning to become pregnant within the next 6 months) or currently breastfeeding, at screening or according to a urine pregnancy test on Day -2 (admission);
•Participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Day 1;
+11 more criteria

Locations (1)

Celerion

Tempe, Arizona, United States

Key Dates

Start Date

November 8, 2019

Primary Completion Date

January 22, 2020

Completion Date

March 31, 2020

Last Updated

August 14, 2023

Enrollment

ACTUAL participants

Conditions

Electrocardiography

Interventions

Avacopan

DRUG

Moxifloxacin

DRUG

Placebo for avacopan

DRUG

Placebo for moxifloxacin

DRUG

Nocturnal Blood Pressure Dipping and Ventricular Repolarization in Hypertension

NCT07200856

HypertensionBlood Pressure Monitoring, Ambulatory+3 more

View study

COMPLETED

Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy

NCT07147920

ECGElectrocardiography+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants

Inclusion Criteria

Exclusion Criteria

Nocturnal Blood Pressure Dipping and Ventricular Repolarization in Hypertension

Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy

Impact of Supraphysiological Estradiol on ECG in IVF Patients

Cardiac Arrest Post-Discharge ECG Monitoring

Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device Among Patient With Chest Pain

Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient With Diabetes and Chronic Kidney Disease