search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
CHF 6001 SD or placebo
CHF 6001 MD or placebo
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Quotient Clinical

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CHF 6001 SD or placebo

CHF 6001 MD or placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adverse events, adverse drug reactions, serious adverse events.
The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events
Vital signs
Blood pressure and Heart rate
12-lead ECG
Heart rate, RR, PR, QRS, QT, QTcB, QTcF
24h ECG Holter
Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)
FEV1
Blood and urine Laboratory tests
Body weight

Secondary Outcome Measures

Pharmacokinetics of CHF 6001 and its metabolite
AUC; Cmax and tmax; t½

Full Information

First Posted
April 2, 2012
Last Updated
July 30, 2020
Sponsor
Chiesi Farmaceutici S.p.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT01703052
Brief Title
Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 6001 SD or placebo
Arm Type
Experimental
Arm Description
Single administration of CHF 6001 dose levels 1 to 7 or placebo
Arm Title
CHF 6001 MD or placebo
Arm Type
Experimental
Arm Description
Multiple administration of CHF 6001 dose levels 1 to 5 or placebo
Intervention Type
Drug
Intervention Name(s)
CHF 6001 SD or placebo
Other Intervention Name(s)
CHF 6001 DPI
Intervention Description
Dry Powder Inhaler
Intervention Type
Drug
Intervention Name(s)
CHF 6001 MD or placebo
Other Intervention Name(s)
CHF 6001 DPI
Intervention Description
Dry Powder Inhaler
Primary Outcome Measure Information:
Title
Adverse events, adverse drug reactions, serious adverse events.
Description
The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events
Time Frame
After 7 days of treatment
Title
Vital signs
Description
Blood pressure and Heart rate
Time Frame
After 7 days of treatment
Title
12-lead ECG
Description
Heart rate, RR, PR, QRS, QT, QTcB, QTcF
Time Frame
After 7 days of treatment
Title
24h ECG Holter
Description
Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)
Time Frame
After 7 days of treatment
Title
FEV1
Time Frame
After 7 days of treatment
Title
Blood and urine Laboratory tests
Time Frame
After 7 days of treatment
Title
Body weight
Time Frame
After 7 days of treatment
Secondary Outcome Measure Information:
Title
Pharmacokinetics of CHF 6001 and its metabolite
Description
AUC; Cmax and tmax; t½
Time Frame
After 7 days of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Mair, MD
Organizational Affiliation
Quotient Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26945156
Citation
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.
Results Reference
background
PubMed Identifier
31077576
Citation
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.
Results Reference
background
PubMed Identifier
30425469
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 Obstruct Pulmon Dis. 2018 Oct 18;13:3399-3410. doi: 10.2147/COPD.S174156. eCollection 2018.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs