A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001

Chronic Obstructive Pulmonary Disease Clinical Trial

— CHF6001Ext  

Official title:

A Phase 1, Randomised Double-blind, Placebo-controlled STUDY of Single and Repeated Ascending doseS in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386761
• Other study ID #: CCD-06001AA1-08
• Status: Completed
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.

Description:

To assess the safety and tolerability of single and repeated ascending doses of CHF 6001 in healthy volunteers and to investigate the pharmacokinetic (PK) profile of CHF 6001 and its metabolites CHF 5956 and CHF 6095.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Main Inclusion

• Subject's written informed consent obtained prior to any study-related procedure

• Male and female Caucasian healthy volunteers aged 18-55 years inclusive

• Vital signs:Subjects aged 18-45: Diastolic BP 40-90, Systolic BP 90-140 Subjects aged 45-55: Diastolic BP 40-90, Systolic BP 90-150 (as mean of three measures performed after at least 5 minutes of resting); checked at screening visit and Day -1

• 12-lead digitised Electrocardiogram (12-lead ECG) considered as normal (40=Heart rate=110bpm,120 ms = PR = 210 ms, QRS = 120 ms, QTcF = 450 ms for males and = 470ms for females) checked at screening visit and Day -1

• Lung function measurements within normal limits: FEV1 > 80% of predicted normal value (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Values (1,2) ) and FEV1/FVC ratio > 0.70

Main Exclusion:

• Pregnant or lactating women

• Clinically significant cardiac abnormalities

• Any clinically relevant abnormal laboratory values

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Single Ascending Dose (SAD)

• Multiple Ascending Dose (MAD)

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	UK

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Jolling K, Äbelö A, Luyckx N, Nandeuil MA, Govoni M, Cella M, Lindauer A. Concentration-QT Modeling Following Inhalation of the Novel Inhaled Phosphodiesterase-4 Inhibitor CHF6001 in Healthy Volunteers Shows an Absence of QT Prolongation. CPT Pharmacometrics Syst Pharmacol. 2019 Jul;8(7):460-468. doi: 10.1002/psp4.12405. Epub 2019 May 11. — View Citation

Mariotti F, Govoni M, Lucci G, Santoro D, Nandeuil MA. Safety, tolerability, and pharmacokinetics of single and repeat ascending doses of CHF6001, a novel inhaled phosphodiesterase-4 inhibitor: two randomized trials in healthy volunteers. Int J Chron Obst — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		0-14 days