NCT04756960

Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: Male
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical trial is a single centre Phase I study, with a single dose, non-randomized, open-label, uncontrolled design. A total of 8 healthy male subjects were included in the study. The aim was to assess the absolute bioavailability, the mass balance, and routes of elimination of CHF6001 (Tanimilast) in healthy male subjects, using \[14\^C\]-radiolabelled drug substance, administered as an intravenous (iv) infusion concomitantly with an inhaled (inh) non-radiolabelled dose of CHF6001. Standard safety assessments were conducted during the study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs, and assessment of any adverse events (AE). Blood, urine, and feces samples were collected for pharmacokinetic (PK) analyses.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• COPD

Interventions

Type	Name	Description
DRUG	CHF6001	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

Timeline

• Start date: 2021-03-10
• Primary completion: 2021-04-29
• Completion: 2021-04-29
• First posted: 2021-02-16
• Last updated: 2024-03-18
• Results posted: 2024-03-18

Locations

1 site across 1 country: United Kingdom