Condition or disease | Intervention/treatment | Phase |
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Asthma | Drug: Treatment A Drug: Treatment B Drug: Treatment C Drug: Treatment D Drug: Treatment E Drug: Treatment F | Phase 1 |
The study consists in two parts. The first study part (Part I) is a single dose, randomised, double-blind, placebo-controlled, 5-way, 5-period crossover design, in healthy subjects.
The second study part (Part II) is a repeated dose, open label treatment in healthy subjects.
The PK of CHF 6532 and CHF 6532 acyl glucuronide metabolite (CHF 6532-AG), the cardiac safety will be assessed after single or repeated administration of CHF 6532 tablet formulations in healthy subjects under fed conditions.
A total of 30 healthy male and female are planned to be included where they will participate the 2 study parts.
Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood and urines samples will be also collected for PK analysis. Holter recordings will be performed to build a prospective concentration-response model of QTc for CHF 6532 in Part I and for cardiac safety purpose at steady state in Part II.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Part I: 5-way, 5-period crossover Part II: single group |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Part II: double blind Part II: open label |
Primary Purpose: | Other |
Official Title: | A Clinical Pharmacology Study to Evaluate the CHF 6532 Linearity After Single Oral Administrations of Four Doses of a Tablet Formulation Followed by an Evaluation of the Pharmacokinetic at Steady State Following the Repeated Open Label b.i.d. Administration at One Dose |
Actual Study Start Date : | May 10, 2019 |
Actual Primary Completion Date : | November 22, 2019 |
Actual Study Completion Date : | November 22, 2019 |
Arm | Intervention/treatment |
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Experimental: Treatment A
Single administration of CHF 6532 Dose #1
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Drug: Treatment A
tablet of CHF 6532
|
Experimental: Treatment B
Single administration of CHF 6532 Dose #2
|
Drug: Treatment B
tablet of CHF 6532
|
Experimental: Treatment C
Single administration of CHF 6532 Dose #3
|
Drug: Treatment C
tablet of CHF 6532
|
Experimental: Treatment D
Single administration of CHF 6532 Dose #4
|
Drug: Treatment D
tablet of CHF 6532
|
Placebo Comparator: Treatment E
Single administration of CHF 6532 Placebo
|
Drug: Treatment E
Placebo tablet of CHF 6532
|
Treatment F
Part II: Administration of tablet of CHF 6532 b.i.d. for 10 days at one dose.
|
Drug: Treatment F
tablet of CHF 6532
|
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
SGS Life Sciences - Clinical Pharmacology Unit Antwerpen | |
Antwerp, Belgium, 2060 |
Tracking Information | |||||
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First Submitted Date ICMJE | May 6, 2019 | ||||
First Posted Date ICMJE | May 8, 2019 | ||||
Last Update Posted Date | July 22, 2020 | ||||
Actual Study Start Date ICMJE | May 10, 2019 | ||||
Actual Primary Completion Date | November 22, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects | ||||
Official Title ICMJE | A Clinical Pharmacology Study to Evaluate the CHF 6532 Linearity After Single Oral Administrations of Four Doses of a Tablet Formulation Followed by an Evaluation of the Pharmacokinetic at Steady State Following the Repeated Open Label b.i.d. Administration at One Dose | ||||
Brief Summary | The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration at one dose. | ||||
Detailed Description |
The study consists in two parts. The first study part (Part I) is a single dose, randomised, double-blind, placebo-controlled, 5-way, 5-period crossover design, in healthy subjects. The second study part (Part II) is a repeated dose, open label treatment in healthy subjects. The PK of CHF 6532 and CHF 6532 acyl glucuronide metabolite (CHF 6532-AG), the cardiac safety will be assessed after single or repeated administration of CHF 6532 tablet formulations in healthy subjects under fed conditions. A total of 30 healthy male and female are planned to be included where they will participate the 2 study parts. Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood and urines samples will be also collected for PK analysis. Holter recordings will be performed to build a prospective concentration-response model of QTc for CHF 6532 in Part I and for cardiac safety purpose at steady state in Part II. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Part I: 5-way, 5-period crossover Part II: single group Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Part II: double blind Part II: open label Primary Purpose: Other
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Condition ICMJE | Asthma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 22, 2019 | ||||
Actual Primary Completion Date | November 22, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03942666 | ||||
Other Study ID Numbers ICMJE | CLI-06532AA1-03 2019-000250-59 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Chiesi Farmaceutici S.p.A. | ||||
Study Sponsor ICMJE | Chiesi Farmaceutici S.p.A. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chiesi Farmaceutici S.p.A. | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |