Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of PUR1900 (Itraconazole Powder) in Healthy Volunteers and Adults With Asthma
Lead Sponsor:
Pulmatrix Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Phase 1, 3-part study to assess safety, tolerability and PK of single and multiple doses of itraconazole administered as a dry powder for inhalation (PUR1900) in healthy subjects (parts 1 and 2) and a...
Detailed Description
Phase 1, multi-center, 3-part, open-label study in healthy adults (Parts 1 and 2) and adults with mild to moderate, stable asthma (Part 3). Safety, tolerability and PK will be assessed following eith...
Eligibility Criteria
Inclusion
- Part 1 (SAD) and Part 2 (MAD):
- Healthy males or non-pregnant, non-lactating healthy females.
- Age 18 to 60 years
- Screening forced expiratory volume in 1 sec (FEV1) ≥80% of the predicted value
- Screening FEV1/forced vital capacity (FVC) \>0.70.
- Able to demonstrate the correct inhalation technique for use of delivery device during the study.
- Part 3 (Asthmatic Subjects):
- Males or non-pregnant, non-lactating females with a physician-confirmed diagnosis of asthma for at least 3 months. Asthma must be assessed by investigator as being stable for at least 4 weeks prior to screening.
- Age 18 to 60 years
- Subject is being treated with either inhaled corticosteroids (ICS) or inhaled corticosteroids plus long-acting beta-agonists (ICS/LABA). Only GINA STEP 2 and 3 patients will be enrolled.
- Pre-bronchodilator, clinic measured, FEV1 ≥70% of predicted normal at screening
- Able to perform the required spirometric testing.
- Able to produce a sputum sample of a quality required for drug concentration assessments (a single repeat is permitted).
Exclusion
- Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing on this study
- Subjects who have previously received IMP in this study. Subjects who have participated in Part 1 are not permitted to participate in Part 2 or Part 3.
- History of any drug or alcohol abuse in the past 2 years prior to screening.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Females of childbearing potential who are pregnant or lactating, or who plan to become pregnant during the study (all female subjects must have a negative pregnancy test at screening). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or is postmenopausal (had no menses for 12 months without an alternative medical cause (will be re-assessed at admission/pre-dose).
- Positive drugs of abuse test result at screening or admission
- Subjects with congestive heart failure or a history of congestive heart failure
- History of severe cough or bronchospasm upon inhalation of any dry powder inhalation product
- Subjects who are taking or have taken any herbal remedies or CYP3A4 inducers in the 28 days prior to the first IMP administration
- Upper respiratory tract infection (excluding otitis media), fever, acute or chronic cough within 14 days of the first IMP administration, or lower respiratory tract infection within the last 3 months prior to IMP administration
- Recent (last 4 weeks prior to IMP administration) clinically significant bacterial, viral or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals or antifungals; topical treatments, other than antifungals, are allowed.
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03479411
Start Date
February 9 2018
End Date
June 28 2018
Last Update
July 27 2018
Active Locations (2)
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1
Medicines Evaluation Unit
Manchester, United Kingdom
2
Quotient Sciences
Nottingham, United Kingdom