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

NCT01703052 | Completed Phase 1 DMC

• 1 other identifier: CCD-1006-PR-0048
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (7)

• 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

• Vital signs

  Blood pressure and Heart rate

  After 7 days of treatment

• 12-lead ECG

  Heart rate, RR, PR, QRS, QT, QTcB, QTcF

  After 7 days of treatment

• 24h ECG Holter

  Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)

  After 7 days of treatment

• FEV1

  After 7 days of treatment

• Blood and urine Laboratory tests

  After 7 days of treatment

• Body weight

  After 7 days of treatment

Secondary Outcomes (1)

• Pharmacokinetics of CHF 6001 and its metabolite

  After 7 days of treatment

Study Arms (2)

CHF 6001 SD or placebo

EXPERIMENTAL

Single administration of CHF 6001 dose levels 1 to 7 or placebo

Drug: CHF 6001 SD or placebo

CHF 6001 MD or placebo

EXPERIMENTAL

Multiple administration of CHF 6001 dose levels 1 to 5 or placebo

Drug: CHF 6001 MD or placebo

Interventions

CHF 6001 SD or placebo DRUG

Dry Powder Inhaler

Also known as: CHF 6001 DPI

CHF 6001 SD or placebo

CHF 6001 MD or placebo DRUG

Dry Powder Inhaler

Also known as: CHF 6001 DPI

CHF 6001 MD or placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Quotient Clinical

Nottingham, United Kingdom

Location

Related 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.

  PMID: 26945156 BACKGROUND

• Jolling K, Abelo 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.

  PMID: 31077576 BACKGROUND

• 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 Obstruct Pulmon Dis. 2018 Oct 18;13:3399-3410. doi: 10.2147/COPD.S174156. eCollection 2018.

  PMID: 30425469 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart Mair, MD

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: October 10, 2012
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

GB (1)