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A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CHF5993
CHF5259
Moxifloxacin 400mg
CHF5993 Placebo
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma

Eligibility Criteria

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

Key Inclusion Criteria: Subject's written informed consent; 18-55 years of age; Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly; Body Mass Index (BMI) between 18 and 32 kg/m2 extremes inclusive; Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year prior to screening; Good physical and mental status, determined on the basis of the medical history and a general clinical examination; Vital signs within normal limits at screening and prior to randomization: Diastolic BP 40-89 mmHg, Systolic BP 90-139 mmHg extremes included (mean value of three measures). Body temperature < 37.5°C; 12 -lead digitized Electrocardiogram (12-lead ECG) in triplicate considered as normal (40 ≤ Heart rate ≤ 110bpm, 120 ms ≤ PR ≤ 220 ms, QRS ≤ 110 ms, QTcF ≤ 450 ms); Lung function measurements within normal limits (normal values: forced expiratory volume in the 1st second [FEV1]/forced vital capacity [FVC] > 0.70 and FEV1 > 80% predicted); Female subjects of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods. Key Exclusion Criteria: Participation in another clinical trial where investigational drug was received and last investigations within the last 8 weeks; Clinically significant abnormal standard ECG at screening; Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with successful completion of this protocol; Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic; Subjects with history of breathing problems (i.e., history of asthma including childhood asthma); Positive urine test for cotinine; Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to randomization, or the subject is expected to take non-permitted concomitant medications during the study; Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or to randomization; Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial; Women who are pregnant or lactating; Use of any kind of smoking electronic devices within 6 months before Screening. Other inclusion/exclusion criteria as defined by the protocol.

Sites / Locations

  • PAREXEL Baltimore Early Phase Clinical UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Single therapeutic dose of CHF5993 (BDP/FF/GB)

Single supra-therapeutic dose of CHF5993 (BDP/FF/GB)

Single supra-therapeutic dose CHF5259 (GB)

Single dose Placebo

Moxifloxacin

Arm Description

Dose: BDP/FF/GB 100/6/12.5 μg, single dose inhalation via pressurized metered dose inhaler (2 puffs from 1 BDP/FF/GB 100/6/12.5 μg pMDI + 2 puffs from 3 placebo pMDI)

Dose: BDP/FF/GB 800/48/100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 BDP/FF/GB 100/6/12.5 μg pMDI)

Dose: GB 100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 GB 12.5 μg pMDI)

Dose: placebo single dose inhalation, via pressurized metered dose inhaler 8 puffs from 4 CHF5993 placebo pMDI

Dose: moxifloxacin 400 mg single dose, for oral use - open label treatment (1 tablet of moxifloxacin 400 mg PO)

Outcomes

Primary Outcome Measures

Effect of BDP/FF/GB pMDI at therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Placebo-adjusted change in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (200/12/25 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.

Secondary Outcome Measures

Effect of BDP/FF/GB pMDI and GB pMDI at supra-therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Placebo-adjusted change from baseline in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Assay sensitivity by demonstrating the effect of a single oral therapeutic dose of moxifloxacin on QTcF.
Placebo-adjusted change from baseline in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on Hearth Rate (HR).
Placebo-adjusted change from baseline of HR (ΔΔHR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on PR interval (PR).
Placebo-adjusted change from baseline of PR (ΔΔPR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on QRS interval (QRS).
Placebo-adjusted change from baseline of QRS (ΔΔQRS) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on individual-corrected QT interval (QTcI)
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Effect of moxifloxacin at therapeutic dose on individual-corrected QT interval.
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Changes in T-wave morphology and U-wave presence.
Frequency of treatment-emergent changes in T-wave morphology and U-wave presence after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Analysis of categorical outliers of Hearth Rate (HR), PR interval (PR), QRS interval (QRS) and QTcF interval (QTcF), after BDP/FF/GB pMDI dosing at therapeutic and supra-therapeutic dose, and after GB dosing at supra-therapeutic dose.
Results of categorical outliers will be summarized by treatment in frequency tables reporting: counts and percentages for number of subjects and number of time points with 1) abnormal actual QTcF values, and 2) abnormal change from baseline of HR, PR, QRS and QTcF. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Analysis of Maximum plasma concentration (Cmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of Cmax after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Area under the curve from 0 to 12 hours post-dose (AUC0-12), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of AUC0-12, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Area under the plasma concentration-time curve from time 0 to time t (AUC0 t), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of AUC0-t after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Area under the curve from time 0 to infinity (AUC0-∞), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of AUC0-∞ after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Time to maximum plasma concentration (tmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of tmax, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Analysis of Terminal half-life (t1/2), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of t1/2, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Incidence of Adverse events
Number and percentage of subjects with at least one event and number of treatment emergent events
Incidence of Adverse Drug Reactions
Number and percentage of subjects with at least one event and number of treatment emergent events
Change of systolic and diastolic blood pressure
Number and percentage of subjects with with abnormal changes from baseline
Body temperature abnormal values
Number and percentage of subjects with at least one event and number of treatment emergent events
Abnormal results of physical examinations
Number and percentage of subjects with at least one event and number of treatment emergent events
Abnormal clinical chemistry and haematology laboratory tests
Number and percentage of subjects with at least one event and number of treatment emergent events

Full Information

First Posted
March 28, 2023
Last Updated
April 13, 2023
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05830071
Brief Title
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
Official Title
A Randomized, Double-blind, Positive and Placebo-controlled, Single-dose, Crossover Study of the Effects of CHF5993 pMDI (BDP/FF/GB) at the Proposed Therapeutic and Supratherapeutic Doses, on the Cardiovascular Safety in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the potential for cardiac repolarization, according to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of CHF5993 pMDI (beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB)) and of one dose of CHF5259 (GB) in healthy subjects compared to moxifloxacin and placebo.
Detailed Description
The main purpose of this study is to evaluate the effect of a single supratherapeutic dose of inhaled BDP/FF/GB on cardiovascular safety. The secondary purposes of the study are to: 1) evaluate the effect of a single supratherapeutic dose of inhaled BDP/FF/GB and GB on cardiovascular safety; 2) establish assay sensitivity by demonstrating the effect of a single oral dose of 400 mg moxifloxacin on cardiovascular safety; 3) determine the pharmacokinetics (PK) of single, inhaled therapeutic and supratherapeutic BDP/FF/GB doses and supratherapeutic GB dose; 4) determine if there is a relationship between the duration of the QTc intervals and the plasma concentrations of the B17MP (beclomethasone 17monopropionate active metabolite of BDP), FF and GB following the administration of BDP/FF/GB and GB pMDIs; 5) generate additional safety and tolerability information.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single therapeutic dose of CHF5993 (BDP/FF/GB)
Arm Type
Experimental
Arm Description
Dose: BDP/FF/GB 100/6/12.5 μg, single dose inhalation via pressurized metered dose inhaler (2 puffs from 1 BDP/FF/GB 100/6/12.5 μg pMDI + 2 puffs from 3 placebo pMDI)
Arm Title
Single supra-therapeutic dose of CHF5993 (BDP/FF/GB)
Arm Type
Experimental
Arm Description
Dose: BDP/FF/GB 800/48/100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 BDP/FF/GB 100/6/12.5 μg pMDI)
Arm Title
Single supra-therapeutic dose CHF5259 (GB)
Arm Type
Experimental
Arm Description
Dose: GB 100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 GB 12.5 μg pMDI)
Arm Title
Single dose Placebo
Arm Type
Placebo Comparator
Arm Description
Dose: placebo single dose inhalation, via pressurized metered dose inhaler 8 puffs from 4 CHF5993 placebo pMDI
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Dose: moxifloxacin 400 mg single dose, for oral use - open label treatment (1 tablet of moxifloxacin 400 mg PO)
Intervention Type
Drug
Intervention Name(s)
CHF5993
Other Intervention Name(s)
beclometasone dipropionate /formoterol fumarate/glycopyrronium bromide, BDP/FF/GB
Intervention Description
BDP/FF/GB 100/6/12.5 μg pMDI
Intervention Type
Drug
Intervention Name(s)
CHF5259
Other Intervention Name(s)
glycopyrronium bromide, GB
Intervention Description
GB 12.5 μg pMDI
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 400mg
Other Intervention Name(s)
Moxifloxacin hydrochloride
Intervention Description
400 mg Oral Tablets
Intervention Type
Drug
Intervention Name(s)
CHF5993 Placebo
Other Intervention Name(s)
BDP/FF/GB Placebo
Intervention Description
placebo pMDI
Primary Outcome Measure Information:
Title
Effect of BDP/FF/GB pMDI at therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Description
Placebo-adjusted change in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (200/12/25 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Secondary Outcome Measure Information:
Title
Effect of BDP/FF/GB pMDI and GB pMDI at supra-therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Description
Placebo-adjusted change from baseline in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Title
Assay sensitivity by demonstrating the effect of a single oral therapeutic dose of moxifloxacin on QTcF.
Description
Placebo-adjusted change from baseline in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG
Time Frame
time 0 (pre-dose) to 6 hours
Title
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on Hearth Rate (HR).
Description
Placebo-adjusted change from baseline of HR (ΔΔHR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Title
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on PR interval (PR).
Description
Placebo-adjusted change from baseline of PR (ΔΔPR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Title
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on QRS interval (QRS).
Description
Placebo-adjusted change from baseline of QRS (ΔΔQRS) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Title
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on individual-corrected QT interval (QTcI)
Description
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Title
Effect of moxifloxacin at therapeutic dose on individual-corrected QT interval.
Description
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 6 hours
Title
Changes in T-wave morphology and U-wave presence.
Description
Frequency of treatment-emergent changes in T-wave morphology and U-wave presence after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Title
Analysis of categorical outliers of Hearth Rate (HR), PR interval (PR), QRS interval (QRS) and QTcF interval (QTcF), after BDP/FF/GB pMDI dosing at therapeutic and supra-therapeutic dose, and after GB dosing at supra-therapeutic dose.
Description
Results of categorical outliers will be summarized by treatment in frequency tables reporting: counts and percentages for number of subjects and number of time points with 1) abnormal actual QTcF values, and 2) abnormal change from baseline of HR, PR, QRS and QTcF. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Time Frame
time 0 (pre-dose) to 24 hours
Title
Analysis of Maximum plasma concentration (Cmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Description
Analysis of Cmax after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Time Frame
time 0 (pre-dose) to 24 hours
Title
Analysis of Area under the curve from 0 to 12 hours post-dose (AUC0-12), pharmacokinetic parameter of FF, GB, BDP and B17MP
Description
Analysis of AUC0-12, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Time Frame
time 0 (pre-dose) to 24 hours
Title
Analysis of Area under the plasma concentration-time curve from time 0 to time t (AUC0 t), pharmacokinetic parameter of FF, GB, BDP and B17MP
Description
Analysis of AUC0-t after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Time Frame
time 0 (pre-dose) to 24 hours
Title
Analysis of Area under the curve from time 0 to infinity (AUC0-∞), pharmacokinetic parameter of FF, GB, BDP and B17MP
Description
Analysis of AUC0-∞ after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Time Frame
time 0 (pre-dose) to 24 hours
Title
Analysis of Time to maximum plasma concentration (tmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Description
Analysis of tmax, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Time Frame
time 0 (pre-dose) to 24 hours
Title
Analysis of Terminal half-life (t1/2), pharmacokinetic parameter of FF, GB, BDP and B17MP
Description
Analysis of t1/2, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Time Frame
time 0 (pre-dose) to 24 hours
Title
Incidence of Adverse events
Description
Number and percentage of subjects with at least one event and number of treatment emergent events
Time Frame
from study start through study completion, an average of 4 months
Title
Incidence of Adverse Drug Reactions
Description
Number and percentage of subjects with at least one event and number of treatment emergent events
Time Frame
from study start through study completion, an average of 4 months
Title
Change of systolic and diastolic blood pressure
Description
Number and percentage of subjects with with abnormal changes from baseline
Time Frame
from study start through study completion, an average of 4 months
Title
Body temperature abnormal values
Description
Number and percentage of subjects with at least one event and number of treatment emergent events
Time Frame
from study start through study completion, an average of 4 months
Title
Abnormal results of physical examinations
Description
Number and percentage of subjects with at least one event and number of treatment emergent events
Time Frame
from study start through study completion, an average of 4 months
Title
Abnormal clinical chemistry and haematology laboratory tests
Description
Number and percentage of subjects with at least one event and number of treatment emergent events
Time Frame
from study start through study completion, an average of 4 months

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
Key Inclusion Criteria: Subject's written informed consent; 18-55 years of age; Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly; Body Mass Index (BMI) between 18 and 32 kg/m2 extremes inclusive; Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year prior to screening; Good physical and mental status, determined on the basis of the medical history and a general clinical examination; Vital signs within normal limits at screening and prior to randomization: Diastolic BP 40-89 mmHg, Systolic BP 90-139 mmHg extremes included (mean value of three measures). Body temperature < 37.5°C; 12 -lead digitized Electrocardiogram (12-lead ECG) in triplicate considered as normal (40 ≤ Heart rate ≤ 110bpm, 120 ms ≤ PR ≤ 220 ms, QRS ≤ 110 ms, QTcF ≤ 450 ms); Lung function measurements within normal limits (normal values: forced expiratory volume in the 1st second [FEV1]/forced vital capacity [FVC] > 0.70 and FEV1 > 80% predicted); Female subjects of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods. Key Exclusion Criteria: Participation in another clinical trial where investigational drug was received and last investigations within the last 8 weeks; Clinically significant abnormal standard ECG at screening; Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with successful completion of this protocol; Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic; Subjects with history of breathing problems (i.e., history of asthma including childhood asthma); Positive urine test for cotinine; Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to randomization, or the subject is expected to take non-permitted concomitant medications during the study; Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or to randomization; Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial; Women who are pregnant or lactating; Use of any kind of smoking electronic devices within 6 months before Screening. Other inclusion/exclusion criteria as defined by the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiesi Clinical trial info
Phone
+39 5021 2791
Email
clinicaltrials_info@chiesi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Goldwater, MDCM/M.SC(A)
Organizational Affiliation
PAREXEL Baltimore Early Phase Clinical Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
PAREXEL Baltimore Early Phase Clinical Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Goldwater, MDCM

12. IPD Sharing Statement

Learn more about this trial

A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)

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