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

Pulmatrix

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Reference Product; Drug: PUR0200

Study type: Interventional

Funder types: Industry

Identifiers

NCT02671825

601-0012P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

42 participants in 7 patient groups

PUR0217a

Experimental group

Description:

PUR0200 formulation 1

Treatment:

Drug: PUR0200

PUR0228a

Experimental group

Description:

PUR0200 formulation 2

Treatment:

Drug: PUR0200

PUR0228b

Experimental group

Description:

PUR0200 formulation 3

Treatment:

Drug: PUR0200

PUR0228c

Experimental group

Description:

PUR0200 formulation 4

Treatment:

Drug: PUR0200

PUR0230c

Experimental group

Description:

PUR0200 formulation 5

Treatment:

Drug: PUR0200

Reference Product 1

Active Comparator group

Description:

Reference Product formulation with active charcoal

Treatment:

Drug: Reference Product

Reference Product 2

Active Comparator group

Description:

Reference Product without active charcoal

Treatment:

Drug: Reference Product