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

NCT02671825 | Completed Phase 1

• 1 other identifier: 601-0012P
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of subjects with treatment-related adverse events

  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

Study Arms (7)

PUR0217a

EXPERIMENTAL

PUR0200 formulation 1

Drug: PUR0200

PUR0228a

EXPERIMENTAL

PUR0200 formulation 2

Drug: PUR0200

PUR0228b

EXPERIMENTAL

PUR0200 formulation 3

Drug: PUR0200

PUR0228c

EXPERIMENTAL

PUR0200 formulation 4

Drug: PUR0200

PUR0230c

EXPERIMENTAL

PUR0200 formulation 5

Drug: PUR0200

Reference Product 1

ACTIVE COMPARATOR

Reference Product formulation with active charcoal

Drug: Reference Product

Reference Product 2

ACTIVE COMPARATOR

Reference Product without active charcoal

Drug: Reference Product

Interventions

PUR0200 DRUG

PUR0200 dry powder inhalation

PUR0217a; PUR0228a; PUR0228b; PUR0228c; PUR0230c

Reference Product DRUG

Dry Powder Inhalation Reference Product

Reference Product 1; Reference Product 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulmatrix Inc.: lead

Study Sites (1)

Tokuda Hospital

Sofia, 1407, Bulgaria

Location

Study Officials

• Valentin Kirkov, MD

  Tokuda Hospital

  PRINCIPAL INVESTIGATOR

• David Hava, PhD

  Pulmatrix Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 11, 2016

Record last verified: 2016-11

Locations

BU (1)