Clinical trial NCT02671825: A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects
Official title: A Phase 1 Single Center, Single Group, 7-way Crossover Pilot Pharmacokinetic Study to Evaluate the Disposition of Active Component Following Single Inhaled Doses of Five Formulations of PUR0200 Compared to Reference Product in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Pulmatrix Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess PK parameter area under the plasma concentration versus time curve (AUC) of 5 formulations of PUR0200 compared to Reference Product
timeFrame: 8 hours
measure: To assess PK parameter Peak Plasma Concentration (Cmax) of 5 formulations of PUR0200 compared to Reference Product
timeFrame: 8 hours
Secondary outcomes:
measure: Number of subjects with treatment-related adverse events
timeFrame: 8 weeks
measure: 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
timeFrame: 8 hours
measure: 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
timeFrame: 8 hours
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Tokuda Hospital
Study officials:
affiliation: Tokuda Hospital
name: Valentin Kirkov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmatrix Inc.
name: David Hava, PhD
role: STUDY_DIRECTOR
References: