At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 8 enrolled
Drug / intervention
CHF6001drug
Likely dose
CHF6001 800 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 Following a Single Inhaled Dose Co-administered With an Intravenous Radiolabelled Microtracer Dose in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating CHF6001 for Chronic Obstructive Pulmonary Disease (COPD) and COPD. Completed, enrolled 8 participants across 1 site.
Detailed Summary
The objective of the study is to evaluate the bioavailability of CHF6001 after inhaled administration, to characterize the mass balance and route of elimination of CHF6001 along with its relevant metabolites, in healthy male subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD), COPD
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartMar 2021
Primary CompletionApr 2021
TodayJul 2026
First PostedFeb 16, 2021
Enrollment StartMar 10, 2021
Primary CompletionApr 29, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.4 years ago
Interventions
CHF6001drug
4 inhalations of CHF6001 800 µg/20 mg NEXThaler® dry-powder inhaler (DPI), (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5 kBq)) of \[14\^C\]-labelled CHF6001