Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control Subjects
NCT05373953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2024-04-15
Summary
A clinical trial to investigate the pharmacokinetics, safety and tolerability of CHF6001 after single administrations in participants with mild, moderate and severe liver impairment with matched healthy adult volunteers
Conditions
Interventions
- DRUG
-
CHF6001
CHF6001 will be administered using the NEXThaler® DPI device
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-05-05
- Primary Completion
- 2022-11-25
- Completion
- 2022-11-25
Countries
- Bulgaria
Study Locations
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