Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device

NCT02119247 | Completed Phase 1

• 2 other identifiers: CCD-06001AA1-072013-005490-41
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®. CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an inhaler device. Previous studies were conducted using a single-dose capsule inhaler (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device will be used.

Conditions

COPD

Keywords

systemic availability , pharmacokinetics, COPD

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration-time curve of CHF 6001

  CHF 6001 AUC0-t (area under the plasma concentration-time curve from time 0 to the last quantifiable concentration) and Cmax (maximum plasma concentration).

  30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at Period 1 and Period 2

Secondary Outcomes (1)

• Other pharmacokinetic parameters for CHF 6001 and metabolites in plasma

  pre-dose, 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at period 1 and 2

Other Outcomes (3)

• Vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP) and Pulse Rate (PR).

  At screening and at DAY 1 period 1 and 2

• Adverse events and adverse drug reactions

  screening visit, and Day1, Day 2, Day 3, Day 4 and Day 5 for both periods 1 and 2 + FU visit/call

• Lung function: FEV1, to assess potential occurrence of paradoxical bronchospasm.

  at sceening and at DAY 1 Period 1 and 2

Study Arms (2)

CHF6001 dry powder for inhalation via NEXThaler®

EXPERIMENTAL

4 inhalations of CHF 6001 NEXThaler®

Device: CHF 6001 dry powder for inhalation via NEXThaler®

CHF 6001 DPI capsules for inhalation via Aerolizer

ACTIVE COMPARATOR

3 inhalations of CHF 6001 capsules via Aerolizer®

Device: CHF 6001 DPI capsules for inhalation via Aerolizer

Interventions

CHF 6001 dry powder for inhalation via NEXThaler® DEVICE

CHF6001 dry powder for inhalation via NEXThaler®

CHF 6001 DPI capsules for inhalation via Aerolizer DEVICE

CHF 6001 DPI capsules for inhalation via Aerolizer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject's written informed consent obtained prior to any study-related procedure
• Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly
• Able to generate sufficient PIF
• Male and female subjects aged 18 to 55 years inclusive
• Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive
• Non- or ex-smokers who smoked \< 5 pack years
• Good physical and mental status
• Lung function within normal limits
• Results of laboratory tests within the normal ranges
• adequate contraception

You may not qualify if:

• Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication
• Pregnant or lactating women
• Positive HIV1 or HIV2 serology
• Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C
• Unsuitable veins for repeated venipuncture
• History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen
• Subjects who have a positive urine test for cotinine at screening or at randomization
• Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation
• Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
• Subjects who have clinically significant cardiovascular condition according to investigator's judgment
• An abnormal 12-lead ECG
• Subjects whose electrocardiogram (12-lead ECG) shows QTcF \> 450 ms for males or QTcF \> 470 ms for females
• Diastolic Blood Pressure \> 90 mmHg and/or Systolic Blood Pressure \> 140 mmHg
• Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening
• History of hypersensitivity to any of the excipients contained in the formulations used in the trial

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

SGS CPU Antwerpen ZNA Stuivenberg

Antwerp, Antwerpen, B-2060, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joe Leempoels, MD

  SGS CPU Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

BE (1)