Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703052
• Other study ID #: CCD-1006-PR-0048
• Status: Completed
• Phase: Phase 1
• Start date: July 2011
• Est. completion date: May 2012

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

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.

Description:

The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part.

Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

• Male healthy volunteers aged 18-55 years;

• Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.

• Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;

• Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking > 1 year;

• Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.

• A reliable method of contraception for the subjects and their partner.

Exclusion Criteria:

• Blood donation or blood loss less than 8 weeks before inhalation of the study medication;

• Positive HIV1 or HIV2 serology;

• Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;

• History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;

• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;

• Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;

• Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).

• Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre.

• Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• CHF 6001 SD or placebo
Dry Powder Inhaler
• CHF 6001 MD or placebo
Dry Powder Inhaler

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Ferrari A, Compagnoni A, Nandeuil A, Maison-Blanche P. Evaluation of the Effects of CHF6001, an Inhaled PDE4 Inhibitor, on Cardiac Repolarization and Cardiac Arrhythmias in Healthy Volunteers. J Cardiovasc Pharmacol. 2016 Jul;68(1):41-8. doi: 10.1097/FJC.0000000000000384. — View Citation

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	Adverse events, adverse drug reactions, serious adverse events.	The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events	After 7 days of treatment
Primary	Vital signs	Blood pressure and Heart rate	After 7 days of treatment
Primary	12-lead ECG	Heart rate, RR, PR, QRS, QT, QTcB, QTcF	After 7 days of treatment
Primary	24h ECG Holter	Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)	After 7 days of treatment
Primary	FEV1		After 7 days of treatment
Primary	Blood and urine Laboratory tests		After 7 days of treatment
Primary	Body weight		After 7 days of treatment
Secondary	Pharmacokinetics of CHF 6001 and its metabolite	AUC; Cmax and tmax; t½	After 7 days of treatment