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Trial record 6 of 1665 for:    ( Map: Bulgaria )

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

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ClinicalTrials.gov Identifier: NCT02671825
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PUR0200 Drug: Reference Product Phase 1

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  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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



Primary Outcome Measures :
  1. To assess PK parameter area under the plasma concentration versus time curve (AUC) of 5 formulations of PUR0200 compared to Reference Product [ Time Frame: 8 hours ]
  2. To assess PK parameter Peak Plasma Concentration (Cmax) of 5 formulations of PUR0200 compared to Reference Product [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Number of subjects with treatment-related adverse events [ Time Frame: 8 weeks ]
    self-reported and investigator-assessed adverse events, vital signs, and laboratory safety examinations

  2. 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 [ Time Frame: 8 hours ]
  3. 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 [ Time Frame: 8 hours ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671825


Locations
Bulgaria
Tokuda Hospital
Sofia, Bulgaria, 1407
Sponsors and Collaborators
Pulmatrix Inc.
Investigators
Principal Investigator: Valentin Kirkov, MD Tokuda Hospital
Study Director: David Hava, PhD Pulmatrix Inc.

Responsible Party: Pulmatrix Inc.
ClinicalTrials.gov Identifier: NCT02671825     History of Changes
Other Study ID Numbers: 601-0012P
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016

Keywords provided by Pulmatrix Inc.:
Pharmacokinetics