HealthyPhase 1NCT02671825
A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects
A Phase 1 study testing PUR0200 and Reference Product in people with Healthy, run by Pulmatrix Inc. at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PUR0200 and Reference Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBulgaria
- Study dates
- Jan 2016to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- PUR0200, Reference Product
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR0200Drug
PUR0200 dry powder inhalation
Reference ProductDrug
Dry Powder Inhalation Reference Product
| Study group | Role | What they receive |
|---|---|---|
| PUR0217a | Experimental | PUR0200 formulation 1 Receives: Drug: PUR0200 |
| PUR0228a | Experimental | PUR0200 formulation 2 Receives: Drug: PUR0200 |
| PUR0228b | Experimental | PUR0200 formulation 3 Receives: Drug: PUR0200 |
| PUR0228c | Experimental | PUR0200 formulation 4 Receives: Drug: PUR0200 |
| PUR0230c | Experimental | PUR0200 formulation 5 Receives: Drug: PUR0200 |
| Reference Product 1 | Active comparator | Reference Product formulation with active charcoal Receives: Drug: Reference Product |
| Reference Product 2 | Active comparator | Reference Product without active charcoal Receives: Drug: Reference Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess PK parameter area under the plasma concentration versus time curve (AUC) of 5 formulations of PUR0200 compared to Reference Product
Measured: 8 hours
To assess PK parameter Peak Plasma Concentration (Cmax) of 5 formulations of PUR0200 compared to Reference Product
Measured: 8 hours
Secondary outcomes (3)
Number of subjects with treatment-related adverse events
self-reported and investigator-assessed adverse events, vital signs, and laboratory safety examinations
Measured: 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
Measured: 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
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valentin Kirkov, MD, Principal investigator, Tokuda HospitalDavid Hava, PhD, Study director, Pulmatrix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671825
- Sponsor's protocol ID
- 601-0012P
- Status last verified
- Nov 2016
- First submitted
- 25 Jan 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02671825
- Acronym / sponsor ID
- 601-0012P
- Conditions
- Healthy
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| PUR0217a | Experimental | Drug: PUR0200PUR0200 formulation 1 |
| PUR0228a | Experimental | Drug: PUR0200PUR0200 formulation 2 |
| PUR0228b | Experimental | Drug: PUR0200PUR0200 formulation 3 |
| PUR0228c | Experimental | Drug: PUR0200PUR0200 formulation 4 |
| PUR0230c | Experimental | Drug: PUR0200PUR0200 formulation 5 |
| Reference Product 1 | Active comparator | Drug: Reference ProductReference Product formulation with active charcoal |
| Reference Product 2 | Active comparator | Drug: Reference ProductReference Product without active charcoal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUR0200PUR0200 dry powder inhalation | Drug | PUR0217a, PUR0228a, PUR0228b, PUR0228c, PUR0230c |
| Reference ProductDry Powder Inhalation Reference Product | Drug | Reference Product 1, Reference Product 2 |
Primary outcome
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
3 secondary outcomes
Number of subjects with treatment-related adverse events
Time frame: 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
Time frame: 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
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
Related trials for Healthy
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin Kirkov, MD principal investigator
Tokuda Hospital
David Hava, PhD study director
Pulmatrix Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PUR0200 and Reference Product in people with Healthy, run by Pulmatrix Inc. at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016; AzTrials last refreshed its copy on 5 Nov 2026.