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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF 6001 SD or placebo

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

Group Type EXPERIMENTAL

CHF 6001 SD or placebo

Intervention Type DRUG

Dry Powder Inhaler

CHF 6001 MD or placebo

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

Group Type EXPERIMENTAL

CHF 6001 MD or placebo

Intervention Type DRUG

Dry Powder Inhaler

Interventions

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CHF 6001 SD or placebo

Dry Powder Inhaler

Intervention Type DRUG

CHF 6001 MD or placebo

Dry Powder Inhaler

Intervention Type DRUG

Other Intervention Names

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CHF 6001 DPI CHF 6001 DPI

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes