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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001 (CHF6001Ext)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Single Ascending Dose (SAD)
Multiple Ascending Dose (MAD)
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

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Quotient Clinical

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single Ascending Dose (SAD)

Multiple Ascending Dose (MAD)

Arm Description

Dose 1 (SAD1): 6 inhalations of CHF 6001 400 µg giving a total dose of 2400 µg Dose 2 (SAD2): 10 inhalations of CHF 6001 400 µg giving a total dose of 4000 µg Dose 3 (SAD3): 12 inhalations of CHF 6001 400 µg giving a total dose of 4800 µg Placebo (P): the number of placebo inhalations will match that of the active CHF 6001 pertaining to the same dose period. In case the actual doses are modified, the number of inhalations will be adapted accordingly.

Dose 1 (MAD1): Multiple doses of CHF 6001 - Total daily dose 2400 µg or placebo Dose 2 (MAD2): Multiple doses of CHF 6001 - Total daily dose 4000 µg or placebo Dose 3 (MAD3): Multiple doses of CHF 6001 - Total daily dose 4800 µg or placebo Duration 14 days b.i.d.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome Measures

Full Information

First Posted
January 22, 2015
Last Updated
July 30, 2020
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02386761
Brief Title
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Single Ascending Dose (SAD)
Arm Type
Experimental
Arm Description
Dose 1 (SAD1): 6 inhalations of CHF 6001 400 µg giving a total dose of 2400 µg Dose 2 (SAD2): 10 inhalations of CHF 6001 400 µg giving a total dose of 4000 µg Dose 3 (SAD3): 12 inhalations of CHF 6001 400 µg giving a total dose of 4800 µg Placebo (P): the number of placebo inhalations will match that of the active CHF 6001 pertaining to the same dose period. In case the actual doses are modified, the number of inhalations will be adapted accordingly.
Arm Title
Multiple Ascending Dose (MAD)
Arm Type
Experimental
Arm Description
Dose 1 (MAD1): Multiple doses of CHF 6001 - Total daily dose 2400 µg or placebo Dose 2 (MAD2): Multiple doses of CHF 6001 - Total daily dose 4000 µg or placebo Dose 3 (MAD3): Multiple doses of CHF 6001 - Total daily dose 4800 µg or placebo Duration 14 days b.i.d.
Intervention Type
Drug
Intervention Name(s)
Single Ascending Dose (SAD)
Other Intervention Name(s)
CHF6001
Intervention Type
Drug
Intervention Name(s)
Multiple Ascending Dose (MAD)
Other Intervention Name(s)
CHF6001
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
0-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
State/Province
UK
ZIP/Postal Code
NG116JS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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

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

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