MedDataX Logo

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

NCT ID: NCT02671825

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pharmacokinetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PUR0217a

PUR0200 formulation 1

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

PUR0200 dry powder inhalation

PUR0228a

PUR0200 formulation 2

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

PUR0200 dry powder inhalation

PUR0228b

PUR0200 formulation 3

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

PUR0200 dry powder inhalation

PUR0228c

PUR0200 formulation 4

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

PUR0200 dry powder inhalation

PUR0230c

PUR0200 formulation 5

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

PUR0200 dry powder inhalation

Reference Product 1

Reference Product formulation with active charcoal

Group Type ACTIVE_COMPARATOR

Reference Product

Intervention Type DRUG

Dry Powder Inhalation Reference Product

Reference Product 2

Reference Product without active charcoal

Group Type ACTIVE_COMPARATOR

Reference Product

Intervention Type DRUG

Dry Powder Inhalation Reference Product

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PUR0200

PUR0200 dry powder inhalation

Intervention Type DRUG

Reference Product

Dry Powder Inhalation Reference Product

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pulmatrix Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valentin Kirkov, MD

Role: PRINCIPAL_INVESTIGATOR

Tokuda Hospital

David Hava, PhD

Role: STUDY_DIRECTOR

Pulmatrix Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokuda Hospital

Sofia, , Bulgaria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

601-0012P

Identifier Type: -

Identifier Source: org_study_id