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

COPD Clinical Trial

Official title:

OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, SINGLE DOSE STUDY IN HEALTHY VOLUNTEERS TO INVESTIGATE THE PHARMACOKINETICS OF CHF 6001 DPI ADMINISTERED USING THE MULTI-DOSE RESERVOIR NEXThaler® DEVICE OR THE CAPSULE FOR ORAL INHALATION VIA AEROLIZER® DEVICE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119247
• Other study ID #: CCD-06001AA1-07
• Secondary ID: 2013-005490-41
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2014
• Last updated: July 31, 2014
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Description:

This is an Open-label, randomized, 2-way cross-over, Phase I study. The study is conducted in 1 single european site. The main scope of the study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 DPI administered using the multi-dose reservoir NEXThaler® device or the single-dose capsule Aerolizer® device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Subject's written informed consent obtained prior to any study-related procedure

2. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly

3. Able to generate sufficient PIF

4. Male and female subjects aged 18 to 55 years inclusive

5. Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive

6. Non- or ex-smokers who smoked < 5 pack years

7. Good physical and mental status

8. Lung function within normal limits

9. Results of laboratory tests within the normal ranges

10. adequate contraception

Exclusion Criteria:

1. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication

2. Pregnant or lactating women

3. Positive HIV1 or HIV2 serology

4. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C

5. Unsuitable veins for repeated venipuncture

6. History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen

7. Subjects who have a positive urine test for cotinine at screening or at randomization

8. Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation

9. Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol

10. Subjects who have clinically significant cardiovascular condition according to investigator's judgment

11. An abnormal 12-lead ECG

12. Subjects whose electrocardiogram (12-lead ECG) shows QTcF > 450 ms for males or QTcF > 470 ms for females

13. Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg

14. Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening

15. History of hypersensitivity to any of the excipients contained in the formulations used in the trial

16. Any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days (2 months for enzyme-inducing or enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital) before the screening visit and likely to receive these treatments until the end of the study procedures with the exception of occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions), hormonal contraceptives and hormonal replacement treatment for post-menopausal women

17. Treatment within the previous 3 months before the screening visit and likely to receive these treatments until the end of the study procedures in the last treatment period with biologic drugs and with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole)

18. Subjects who refuse to respect the required study restrictions related to alcohol, xanthine, grapefruit, food and water intake and strenuous activities

19. Heavy caffeine drinker

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• CHF 6001 dry powder for inhalation via NEXThaler®

• CHF 6001 DPI capsules for inhalation via Aerolizer

Locations

Country	Name	City	State
Belgium	SGS CPU Antwerpen ZNA Stuivenberg	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP) and Pulse Rate (PR).		At screening and at DAY 1 period 1 and 2	Yes
Other	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	Yes
Other	Lung function: FEV1, to assess potential occurrence of paradoxical bronchospasm.		at sceening and at DAY 1 Period 1 and 2	Yes
Primary	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	No
Secondary	Other pharmacokinetic parameters for CHF 6001 and metabolites in plasma	CHF 6001 AUC0-2h, AUC0-96h, AUC0-8, tmax (time to Cmax), t½ (terminal elimination half-life ), CHF 5956 and CHF 6095 AUC0-t, Cmax, AUC0-2h, AUC0-96h, AUC0-8, tmax, t½.	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	No