A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects
- Registration Number
- NCT02671825
- Lead Sponsor
- Pulmatrix Inc.
- Brief Summary
The purpose of this study is to compare drug blood levels of multiple formulations of inhaled PUR0200 to each other and to the reference product with and without oral charcoal.
- Detailed Description
The purpose of this study is to compare 5 different formulations of PUR0200 to the reference product. All formulations will be inhaled. In 6 of the 7 study periods either PUR0200 or the reference product will be inhaled under fasting conditions without oral charcoal. In the 7th study period, half of the subjects will receive reference with oral charcoal and the other half will receive reference product without oral charcoal.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Healthy male or female subject
- Age between 18 and 50 (inclusive) years
- Non-smokers or ex-smokers (stopped at least 6 months ago)
- FEV1 ≥80% of the predicted value
- Completion of 3 training inhalations
Exclusion Criteria
- Pregnant and/or nursing women. Positive pregnancy test at entry visit or on hospitalization day 0 of each study period.
- fertile women without reliable contraception
- participation in ANY research study within 3 months prior to entry visit, or simultaneous participation in another clinical study
- blood donation or blood loss within last 3 months
- treatment with ANY investigational study drug (i.e. drug not yet approved) in the last 3 months before entry visit
- intake or administration of any prescribed systemic or topical medication including over the counter (OTC) medication or natural food supplements (e.g. vitamins, garlic, or ginger capsules) within 2 weeks before entry visit
- current or history of drug abuse within 5 years before entry visit
- alcohol abuse
- regular consumption of beverages or food containing methylxanthines (i.e. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines* per day
- presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- major surgery of the gastrointestinal tract except for appendectomy, or any pulmonary surgery
- clinically significant illness (including upper or lower respiratory infection and/or candidiasis of the mouth and throat) within 4 weeks before entry visit
- any acute or chronic disease which might interfere with inhalation, absorption, distribution, metabolism or excretion of the drug special diet due to any reason, e.g. vegetarians
- positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
- excessive physical activity (more than 4 times per week for more than 90 minutes) within the last 6 months and during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PUR0228a PUR0200 PUR0200 formulation 2 PUR0228b PUR0200 PUR0200 formulation 3 PUR0230c PUR0200 PUR0200 formulation 5 PUR0217a PUR0200 PUR0200 formulation 1 Reference Product 1 Reference Product Reference Product formulation with active charcoal PUR0228c PUR0200 PUR0200 formulation 4 Reference Product 2 Reference Product Reference Product without active charcoal
- Primary Outcome Measures
Name Time Method To assess PK parameter area under the plasma concentration versus time curve (AUC) of 5 formulations of PUR0200 compared to Reference Product 8 hours To assess PK parameter Peak Plasma Concentration (Cmax) of 5 formulations of PUR0200 compared to Reference Product 8 hours
- Secondary Outcome Measures
Name Time Method Number of subjects with treatment-related adverse events 8 weeks self-reported and investigator-assessed adverse events, vital signs, and laboratory safety examinations
Comparison of PK parameters (AUC and Cmax) in subjects dosed with Reference product after ingesting charcoal and without charcoal to assess oral vs inhalation exposure of drug 8 hours Comparison of PK parameters (AUC and Cmax) in subjects dosed with Reference product in 2 separate periods to assess the intra-subject variability of inhalation exposure to Reference product 8 hours
Trial Locations
- Locations (1)
Tokuda Hospital
🇧🇬Sofia, Bulgaria