A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PUR0200; Drug: Reference Product

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1407
    • Tokuda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PUR0217a; PUR0200 formulation 1	Drug: PUR0200; PUR0200 dry powder inhalation
Experimental: PUR0228a; PUR0200 formulation 2	Drug: PUR0200; PUR0200 dry powder inhalation
Experimental: PUR0228b; PUR0200 formulation 3	Drug: PUR0200; PUR0200 dry powder inhalation
Experimental: PUR0228c; PUR0200 formulation 4	Drug: PUR0200; PUR0200 dry powder inhalation
Experimental: PUR0230c; PUR0200 formulation 5	Drug: PUR0200; PUR0200 dry powder inhalation
Active Comparator: Reference Product 1; Reference Product formulation with active charcoal	Drug: Reference Product; Dry Powder Inhalation Reference Product
Active Comparator: Reference Product 2; Reference Product without active charcoal	Drug: Reference Product; Dry Powder Inhalation Reference Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Number of subjects with treatment-related adverse events	self-reported and investigator-assessed adverse events, vital signs, and laboratory safety examinations	8 weeks
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

Collaborators and Investigators

• Sponsor: Pulmatrix Inc.
• Investigators: Principal Investigator: Valentin Kirkov, MD, Tokuda Hospital; Study Director: David Hava, PhD, Pulmatrix Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Other Study ID Numbers: 601-0012P