Status:
TERMINATED
Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Cystic Fibrosis, Pulmonary
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single doses of ARO-ENaC in healthy adult volunteers; and to evaluate the safety, tolerability, PK and ef...
Eligibility Criteria
Inclusion
- Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
- Willing to provide written informed consent and to comply with study requirements
- Normal electrocardiogram (ECG) at Screening
- Non-smoking
- Normal pulmonary function tests at Screening (NHVs only)
- No abnormal finding of clinical relevance at Screening other than CF for CF patients
- Confirmed diagnosis of CF based on source verifiable medical record (CF patients only)
- All other treatments for CF have been stable for at least 2 months and patient is willing to continue this treatment regimen without change for duration of study (CF patients only)
Exclusion
- Acute lower respiratory infection within 30 days of Screening (NHVs only)
- History of asthma (specifically, those subjects at risk of bronchial hyperactivity), anaphylaxis or airway hyper-reactivity
- Clinically significant history of hyperkalemia or presence of hyperkalemia at Screening
- Clinically significant health concerns (other than CF in CF patients)
- Human Immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
- Uncontrolled hypertension
- Excessive use of alcohol within one month prior to Screening
- Use of illicit drugs within 1 year prior to Screening
- Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
- CF exacerbation within 30 days of Dosing (CF patients)
- History of solid organ transplant (CF patients)
- Diagnosis of hepatic cirrhosis (CF patients)
- Note: additional inclusion/exclusion criteria may apply per protocol
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04375514
Start Date
July 30 2020
End Date
May 13 2022
Last Update
December 17 2025
Active Locations (7)
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1
Research Site 3
Chermside, Queensland, Australia, 4032
2
Research Site 4
South Brisbane, Queensland, Australia, 4101
3
Research Site 1
Nedlands, Washington, Australia, 6009
4
Research Site 2
Hamilton, Australia, 3204