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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01703052
First received: April 2, 2012
Last updated: October 8, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: CHF 6001 SD or placebo
Drug: CHF 6001 MD or placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Adverse events, adverse drug reactions, serious adverse events. [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: Yes ]
    The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events

  • Vital signs [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: Yes ]
    Blood pressure and Heart rate

  • 12-lead ECG [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: Yes ]
    Heart rate, RR, PR, QRS, QT, QTcB, QTcF

  • 24h ECG Holter [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: Yes ]
    Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)

  • FEV1 [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: Yes ]
  • Blood and urine Laboratory tests [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of CHF 6001 and its metabolite [ Time Frame: After 7 days of treatment ] [ Designated as safety issue: No ]
    AUC; Cmax and tmax; t½


Enrollment: 74
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF 6001 SD or placebo
Single administration of CHF 6001 dose levels 1 to 7 or placebo
Drug: CHF 6001 SD or placebo
Dry Powder Inhaler
Other Name: CHF 6001 DPI
Experimental: CHF 6001 MD or placebo
Multiple administration of CHF 6001 dose levels 1 to 5 or placebo
Drug: CHF 6001 MD or placebo
Dry Powder Inhaler
Other Name: CHF 6001 DPI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703052

Locations
United Kingdom
Quotient Clinical
Nottingham, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Stuart Mair, MD Quotient Clinical
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01703052     History of Changes
Other Study ID Numbers: CCD-1006-PR-0048
Study First Received: April 2, 2012
Last Updated: October 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014