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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2016
• Main ID: NCT02671825
• Date of registration: 25/01/2016
• Prospective Registration: No
• Primary sponsor: Pulmatrix Inc.
• Public title: A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects
• Scientific 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
• Date of first enrolment: January 2016
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02671825
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Bulgaria

Contacts

• Name: Valentin Kirkov, MD
• Affiliation: Tokuda Hospital

• Name: David Hava, PhD
• Affiliation: Pulmatrix Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Reference Product

Drug: PUR0200

Primary Outcome(s)

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]

To assess PK parameter Peak Plasma Concentration (Cmax) of 5 formulations of PUR0200 compared to Reference Product [Time Frame: 8 hours]

Secondary Outcome(s)

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]

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]

Number of subjects with treatment-related adverse events [Time Frame: 8 weeks]

Secondary ID(s)

601-0012P

Source(s) of Monetary Support

Please refer to primary and secondary sponsors