Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 12 for:    "CHF 5993" AND "asthma"

Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359292
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
The study is performed to evaluate the total systemic exposure and lung bioavailability of CHF 5993 pMDI combination, in healthy volunteers subjects.

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF 5993 HS 200/6/25 pMDI Drug: CHF 5993 MS 100/6/25 pMDI Drug: CHF 5993 HS 200/6/25 pMDI + Charcoal Block Drug: CHF 5993 MS 100/6/25 pMDI + Charcoal Block Drug: Placebo pMDI Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cross-over Clinical Pharmacology Study, to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination Across Two Different Dose Strengths, Administered With and Without Activated Charcoal, in Healthy Volunteers
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CHF 5993 HS 200/6/25 pMDI
High Strength fixed combination
Drug: CHF 5993 HS 200/6/25 pMDI
Active Comparator: CHF 5993 MS 100/6/25 pMDI
Medium Strength fixed combination
Drug: CHF 5993 MS 100/6/25 pMDI
Experimental: CHF 5993 HS 200/6/25 pMDI + Charcoal Block
High Strength fixed combination plus Charcoal Block
Drug: CHF 5993 HS 200/6/25 pMDI + Charcoal Block
Active Comparator: CHF 5993 MS 100/6/25 pMDI + Charcoal Block
Medium Strength fixed combination plus Charcoal Block
Drug: CHF 5993 MS 100/6/25 pMDI + Charcoal Block
Placebo Comparator: Placebo pMDI
Placebo
Drug: Placebo pMDI



Primary Outcome Measures :
  1. Systemic exposure of B17MP, Formoterol and Glycopyrronium bromide, without charcoal block (To evaluate the total systemic exposure as AUCt and Cmax) Composite outcome measures of PK variables [ Time Frame: over 32hours after administration ]
    Composite outcome measures of PK variables

  2. Lung exposure of B17MP, Formoterol and Glycopyrronium bromide without charcoal block (To evaluate the lung exposure (as AUCt and Cmax) Composite outcome measures of PK variables [ Time Frame: over 32hours after administration ]
    Composite outcome measures of PK variables


Secondary Outcome Measures :
  1. Systemic effects of CHF5993 (To evaluate the systemic effects as potassium and glucose levels) Composite outcome measures of PD variables [ Time Frame: over 24hours after administration ]
    Composite outcome measures of PD variables

  2. Systemic cardiac effects and the general safety (Composite outcome measures of cardiac variables (such as HR, BP, QT) and safety variables (such as AE, SAE) [ Time Frame: over 24hours after administration ]
    Composite outcome measures of cardiac variables (such as HR, BP, QT) and safety variables (such as AE, SAE)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. Male and female subjects aged 18 to 55 years inclusive.
  4. Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive.
  5. 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 prior to screening.
  6. Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and before randomization.
  7. Lung function measurements within normal limits (Normal values (according to GINA 2014 document): FEV1/FVC > 0.70 and FEV1 > 80% predicted).
  8. Male subjects: they and/or their partner must be willing to use an approved method of contraception from the time of screening and until 30 days after the last dose of study. Subjects must not donate sperm for 30 days after the last dose of study drug.*
  9. Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant), using an acceptable method of contraception
  10. Surgical sterilization (i.e. bilateral tubal ligation, hysterectomy for females; vasectomy for males)
  11. Hormonal contraception (implantable, injectable, patch, oral)
  12. Double-barrier methods: condom and occlusive cap (diaphragm or cervical/vault caps)
  13. Placement of an intrauterine device (IUD) or intrauterine system (IUS).

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. Female subjects: pregnant or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of the gestation) confirmed by a positive urine test at screening and randomization.
  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 alcohol abuse within 12 months prior to screening.
  7. History of drug abuse within 12 months prior to screening (or positive urine drug test performed at screening).
  8. Subjects who have a positive urine test for cotinine.
  9. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation. Note: In case of abnormal laboratory values, the test can be performed again once before randomization.
  10. Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.
  11. History of glaucoma, symptomatic prostatism or urinary retention.
  12. Subjects who have cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months (sustained means lasting more than 30 seconds and or ending only with external action, and or leads to hemodynamic collapse; non-sustained means > 3 beats < 30 seconds, and or ending spontaneously, and or asymptomatic), impulse conduction high degree blocks, ICD implant
  13. Abnormal ECG (i.e.: QRS > 120 msec, PR > 220 msec, HR < 40 bpm, HR > 110 bpm, QTcF > 450 ms for males or QTcF > 470 ms for females) at screening.

    Note: In case of abnormal ECG, the test can be performed again once before randomization.

  14. Clinically significant abnormal 24h-Holter monitoring at screening (if necessary the Holter evaluation can be done on another day before randomization).
  15. Abnormal Blood Pressure (Average Diastolic Blood Pressure > 90 mmHg or average Systolic Blood Pressure > 140 mmHg) at screening.

    Note: In case of abnormal blood pressure, measure can be done again once before randomization.

  16. Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening.
  17. History of hypersensitivity to any of the excipients contained in the formulations used in the trial.
  18. Subject taking any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days before the screening with the exception of :

    1. Occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions);
    2. Hormonal contraceptives;
    3. Hormonal replacement treatment for post-menopausal women.
  19. Subject taking treatment, with enzyme-inducing or enzyme-inhibiting drugs and biologic drugs and with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole), taken since 3 months before screening until randomization.
  20. Heavy caffeine drinker (> 5 caffeinated beverages e.g., coffee, tea, cola per day).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359292


Locations
Layout table for location information
Belgium
SGS CPU Antwerpen
Antwerpen, Belgium
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.

Layout table for additonal information
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02359292    
Other Study ID Numbers: CCD-05993AB2-01
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs