HealthyPhase 1NCT05351086
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults
A Phase 1 study testing PUR3100 and Dihydroergotamine (D.H.E 45) in people with Healthy, run by Pulmatrix Inc. at 1 site in Australia.
Trial summary
A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Healthy Adults Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PUR3100 and Dihydroergotamine (D.H.E 45)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jun 2022to 22 Sep 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged 18 to 55 years of age with a body mass index ≥17 and ≤35 kg/m2.
- Subject has normal screening and baseline blood pressure, defined as a systolic value ≥90 mmHg and ≤140 mmHg and a diastolic value >60 mmHg and <90 mmHg.
- Female subjects who are of childbearing potential and male subjects with female partner(s) of childbearing potential must agree to use an effective contraceptive throughout the study (e.g., oral contraceptives or Norplant®; a reliable double barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices; partner with vasectomy; or abstinence) and for at least 90 days after study drug administration. In addition, female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing. Note: Women of non-childbearing potential may be enrolled if they are:
- Surgically sterile (e.g., hysterectomy with or without oophorectomy; fallopian tube ligation; endometrial ablation), for at least 30 days prior to signing the ICF
- Post-menopausal (≥ 12 consecutive months of spontaneous amenorrhea and > 50 years of age)
- Female subjects must agree not to donate ova/oocytes during the study and for 90 days after the last dose of IMP.
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- Male subject must agree not to donate semen during the study and for 90 days after the last dose of IMP.
- Subject is able and willing to abstain from alcohol for 48 hours prior to admission to the study unit and throughout the entire study until completion of the Day 7 follow up visit.
- Subject is willing to participate in the study, comply with the study requirements, and voluntarily provide written informed consent.
- Subject can read, write, and speak English.
- Subject is mentally competent to provide informed consent.
- Subject can perform technically acceptable spirometry at screening.
- Subject can demonstrate the correct inhalation technique for use of the delivery device and to generate sufficient peak inspiratory flow (PIF) of at least 40 L/min using the In-Check DIAL device at screening.
Who cannot join
- Subject has a history of proven or suspected coronary artery disease (CAD), coronary vasospasm (including Prinzmetal's angina), peripheral vascular disease, or other ischemic diseases (e.g., ischemic bowel syndrome or Raynaud's syndrome) or cardiac disorder (e.g., any clinically significant dysrhythmia), any history of heart attack or stroke, hypertension, diabetes mellitus, liver or kidney disease, aortic aneurysm, chronic pulmonary disease, or recent (within 3 months) sepsis or vascular surgery.
- Subject has a current diagnosis of asthma, chronic obstructive pulmonary disease, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung disease, known alpha-1 antitrypsin deficiency, or other active pulmonary disease.
- Subject has clinically significant abnormal laboratory values at screening that, in the opinion of the investigator would make the subject inappropriate for the study or put the subject at undue risk, specifically liver function tests (LFTs) >1.5 times the upper limit of normal (ULN); hemoglobin <10 gm/dL; absolute neutrophil count (ANC) <2.0 x 109/L; white blood cells (WBC) ˃11 x 109/L; platelets <100,000 or >500,000; international normalization ratio (INR) >1.3.
- Subject has a QTcF of >450 msec in males or >470 msec in females at screening.
- Subject has forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) on screening spirometry that is less than 80% predicted.
- Subject has a history of illicit drug or alcohol abuse within the past 12 months prior to screening.
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- Subject smokes more than 5 cigarettes per day or vapes more than 5 times per day with devices that deliver nicotine.
- Subject has a history of nicotine replacement products daily within 6 months prior to screening.
- Subject has a positive alcohol test result at screening.
- Subject has a positive urine drug test result at screening, unless the result can be explained by the subject's current medications, in which case the PI should discuss the disposition of the subject with the Sponsor. Cannabidiol (CDB) and tetrahydro cannabinol (THC) use is prohibited.
- Subject has a known sensitivity to the study drug or any of the excipients of the formulation, or history of clinically significant sensitivity to any agent that, in the opinion of the investigator, would make participation in the study inadvisable.
- Subject has donated blood or blood products or had substantial loss of blood (more than 500 mL) within 6 weeks prior to screening.
- Subject has participated in an interventional study involving an experimental therapeutic agent within 3 months of screening.
- Women who have a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening or a positive urinary hCG pregnancy test prior to dosing, is pregnant, lactating, or planning to become pregnant during the study or within 90 days after conclusion of study participation.
- Subject has a positive hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) test result. Subjects who are hepatitis B surface (HBs) antibody positive or hepatitis B (HB) core antibody positive are not excluded provided the HBsAg result is negative. Subjects who are HCV antibody positive are not excluded if a subsequent HCV RNA test is negative.
- Subject has a planned surgery or procedure during participation in the study and for 28 days after the conclusion of study participation.
- Subject is an employee of the investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site or is a family member of a study site employee or the investigator.
- Subject has a current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
- The subject is unable or unwilling to comply fully with the study protocol.
- Subject is mentally or legally incapacitated.
- Subject is unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation.
- There is a condition or situation that, in the opinion of the investigator, would make participation in the study inadvisable.
- Subject has a history of chronic uncontrolled disease including, but not limited to, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematologic, urologic, immunologic, or ophthalmic diseases that, in the opinion of the investigator, would make participation in the study inadvisable.
- Subject has had major surgery within 6 weeks prior to screening.
- Subject has a disclosed history, or one known to the investigator, of significant noncompliance in previous investigational studies or with prescribed medications.
- Subject requires supplemental oxygen, even on an occasional basis.
- Subject received a live vaccine within 14 days prior to screening.
- Caffeine-containing beverage e.g coffee, tea, or caffeine sodas or power drinks (greater than 3 cups per day, 1 cup=250 mL) within 3 months prior to screening. Subject is UN able and unwilling to abstain from tea, coffee, or caffeine-containing beverages for 48 hours prior to admission to the study unit and throughout the entire study until completion of the Day 7 follow up visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults
A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Healthy Adults
Read the detailed description
This is a randomized, parallel group, double-blind, double dummy study.
Following screening and confirmation of eligibility, twenty-four healthy subjects will be evenly randomized to 1 of the 4 dose groups of 6 subjects each. Subjects will receive intravenous (IV) dihydroergotamine (D.H.E) or IV placebo and dry powder inhalation of 0.5mg of PUR3100, 1.0 mg of PUR 3100, 1.5 mg of PUR 3100, or placebo.
All potential subjects will complete screening between 28 days and 2 days prior to study unit check-in on Day -1. Subjects will remain in the study unit for 3 days post check-in and will be dosed each day at the study site.
A follow up visit will occur 4 days after the last dose of study drug, on Day 7 of the study.
- Conditions
- Healthy
- Being tested
- PUR3100, Dihydroergotamine (D.H.E 45), Matching Placebo for PUR3100, Matching Placebo for D.H.E 45
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR3100Drug
PUR3100 is an inhalation powder containing DHE, an anti-migraine treatment with broad spectrum agonist activity against 5-hydroxytryptamine (5-HT), dopamine, and adrenergic receptors. PUR3100 is provided as 500 µg dose strength capsules. Each capsule contains the drug substance, DHE mesylate, with mannitol, leucine, and sodium chloride as excipients.
Dihydroergotamine (D.H.E 45)Drug
D.H.E. 45 is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. It is supplied as a clear, colorless solution supplied in sterile ampules for IV, intramuscular, or subcutaneous administration containing (per mL) DHE mesylate, USP 1 mg, ethanol, 94% w/w. 6.2% by volume, glycerin 15% by weight, and water for injection.
Matching Placebo for PUR3100Other
Each capsule of matching placebo is filled with iSPERSE powder comprised of mannitol, leucine, and sodium chloride. The PUR3100 inhalation powder is administered using the supplied RS01 inhalation device (RS01 UHR2, Plastiape S.p.A.).
Matching Placebo for D.H.E 45Other
The matching placebo for D.H.E. 45 is 0.9% sterile saline for injection.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled placebo and IV D.H.E. 45 1 mg | Experimental | Not described Receives: Drug: Dihydroergotamine (D.H.E 45); Other: Matching Placebo for PUR3100 |
| Inhaled PUR3100 0.5 mg and IV placebo | Experimental | Not described Receives: Drug: PUR3100; Other: Matching Placebo for D.H.E 45 |
| Inhaled PUR3100 1.0 mg and IV placebo | Experimental | Not described Receives: Drug: PUR3100; Other: Matching Placebo for D.H.E 45 |
| Inhaled PUR3100 1.5 mg and IV placebo | Experimental | Not described Receives: Drug: PUR3100; Other: Matching Placebo for D.H.E 45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To determine the safety and tolerability of single doses of inhaled PUR3100 in healthy through the review of AEs
Measured: Day 1 through Day 3adult subjects
Maximum Plasma Concentration [Cmax]
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the maximum drug concentration in blood plasma.
This will also be compared to Cmax of participants who receive IV D.H.E. 45.
Measured: Day 1 through Day 3
Last Observed Plasma Concentration [Clast]
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the last observed quantifiable concentration of PUR 3100 in blood plasma.
This will also be compared to Clast of participants who receive IV D.H.E. 45.
Measured: Day 1 through Day 3
Time to Peak Drug Concentration [Tmax]
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time time it takes for a drug to reach the maximum concentration (Cmax).
This will also be compared to Tmax of participants who receive IV D.H.E. 45.
Measured: Day 1 through Day 3
Time of last measurable concentration [Tlast]
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time time it takes for a drug to reach the last measurable concentration of PUR 3100 in blood plasma.
This will also be compared to Tlast of participants who receive IV D.H.E. 45.
Measured: Day 1 through Day 3
Area under the curve [AUC (0-t), AUC (0-inf), AUC (0-2h)]
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the drug concentration in blood plasma over time.
This will also be compared to the AUC (0-t), AUC (0-inf), and AUC (0-2h) of participants who receive IV D.H.E. 45.
Measured: Day 1 through Day 3
Half Life [ t 1/2 ]
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time it takes for the amount of drug in the blood to reduce by 50%.
This will also be compared to the half life of participants who receive IV D.H.E. 45.
Measured: Day 1 through 3
Clearance (CL/F)
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects.
This will also be compared to the CL/F of participants who receive IV D.H.E. 45.
Measured: Day 1 through Day 3
Apparent Volume of Distribution During Terminal Phase (Vz/F)
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects.
This will also be compared to the Vz/F of participants who receive IV D.H.E. 45.
Measured: Day 1 through Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start9 Jun 2022
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
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
- Factorial
- Model description
- Double Dummy, Double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351086
- Sponsor's protocol ID
- 601-0022
- Status last verified
- Dec 2022
- First submitted
- 19 Apr 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults
- ClinicalTrials.gov ID
- NCT05351086
- Acronym / sponsor ID
- 601-0022
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- 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.
A Double Dummy, Double-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Healthy Adults
Detailed description
This is a randomized, parallel group, double-blind, double dummy study.
Following screening and confirmation of eligibility, twenty-four healthy subjects will be evenly randomized to 1 of the 4 dose groups of 6 subjects each. Subjects will receive intravenous (IV) dihydroergotamine (D.H.E) or IV placebo and dry powder inhalation of 0.5mg of PUR3100, 1.0 mg of PUR 3100, 1.5 mg of PUR 3100, or placebo.
All potential subjects will complete screening between 28 days and 2 days prior to study unit check-in on Day -1. Subjects will remain in the study unit for 3 days post check-in and will be dosed each day at the study site.
A follow up visit will occur 4 days after the last dose of study drug, on Day 7 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double Dummy, Double-blind
| Arm | Type | Receives |
|---|---|---|
| Inhaled placebo and IV D.H.E. 45 1 mg | Experimental | Drug: Dihydroergotamine (D.H.E 45), Other: Matching Placebo for PUR3100 |
| Inhaled PUR3100 0.5 mg and IV placebo | Experimental | Drug: PUR3100, Other: Matching Placebo for D.H.E 45 |
| Inhaled PUR3100 1.0 mg and IV placebo | Experimental | Drug: PUR3100, Other: Matching Placebo for D.H.E 45 |
| Inhaled PUR3100 1.5 mg and IV placebo | Experimental | Drug: PUR3100, Other: Matching Placebo for D.H.E 45 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female subjects aged 18 to 55 years of age with a body mass index ≥17 and ≤35 kg/m2.
- Subject has normal screening and baseline blood pressure, defined as a systolic value ≥90 mmHg and ≤140 mmHg and a diastolic value >60 mmHg and <90 mmHg.
- Female subjects who are of childbearing potential and male subjects with female partner(s) of childbearing potential must agree to use an effective contraceptive throughout the study (e.g., oral contraceptives or Norplant®; a reliable double barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices; partner with vasectomy; or abstinence) and for at least 90 days after study drug administration. In addition, female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing. Note: Women of non-childbearing potential may be enrolled if they are:
- Female subjects must agree not to donate ova/oocytes during the study and for 90 days after the last dose of IMP.
- Male subject must agree not to donate semen during the study and for 90 days after the last dose of IMP.
Key exclusion criteria (28 listed)
- Subject has a history of proven or suspected coronary artery disease (CAD), coronary vasospasm (including Prinzmetal's angina), peripheral vascular disease, or other ischemic diseases (e.g., ischemic bowel syndrome or Raynaud's syndrome) or cardiac disorder (e.g., any clinically significant dysrhythmia), any history of heart attack or stroke, hypertension, diabetes mellitus, liver or kidney disease, aortic aneurysm, chronic pulmonary disease, or recent (within 3 months) sepsis or vascular surgery.
- Subject has a current diagnosis of asthma, chronic obstructive pulmonary disease, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung disease, known alpha-1 antitrypsin deficiency, or other active pulmonary disease.
- Subject has clinically significant abnormal laboratory values at screening that, in the opinion of the investigator would make the subject inappropriate for the study or put the subject at undue risk, specifically liver function tests (LFTs) >1.5 times the upper limit of normal (ULN); hemoglobin <10 gm/dL; absolute neutrophil count (ANC) <2.0 x 109/L; white blood cells (WBC) ˃11 x 109/L; platelets <100,000 or >500,000; international normalization ratio (INR) >1.3.
- Subject has a QTcF of >450 msec in males or >470 msec in females at screening.
- Subject has forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) on screening spirometry that is less than 80% predicted.
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 |
|---|---|---|
| PUR3100PUR3100 is an inhalation powder containing DHE, an anti-migraine treatment with broad spectrum agonist activity against 5-hydroxytryptamine (5-HT), dopamine, and adrenergic receptors. PUR3100 is provided as 500 µg dose strength capsules. Each capsule contains the drug substance, DHE mesylate, with mannitol, leucine, and sodium chloride as excipients. | Drug | Inhaled PUR3100 0.5 mg and IV placebo, Inhaled PUR3100 1.0 mg and IV placebo, Inhaled PUR3100 1.5 mg and IV placebo |
| Dihydroergotamine (D.H.E 45)D.H.E. 45 is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. It is supplied as a clear, colorless solution supplied in sterile ampules for IV, intramuscular, or subcutaneous administration containing (per mL) DHE mesylate, USP 1 mg, ethanol, 94% w/w. 6.2% by volume, glycerin 15% by weight, and water for injection. | Drug | Inhaled placebo and IV D.H.E. 45 1 mg |
| Matching Placebo for PUR3100Each capsule of matching placebo is filled with iSPERSE powder comprised of mannitol, leucine, and sodium chloride. The PUR3100 inhalation powder is administered using the supplied RS01 inhalation device (RS01 UHR2, Plastiape S.p.A.). | Other | Inhaled placebo and IV D.H.E. 45 1 mg |
| Matching Placebo for D.H.E 45The matching placebo for D.H.E. 45 is 0.9% sterile saline for injection. | Other | Inhaled PUR3100 0.5 mg and IV placebo, Inhaled PUR3100 1.0 mg and IV placebo, Inhaled PUR3100 1.5 mg and IV placebo |
Primary outcome
Safety and Tolerability
Time frame: Day 1 through Day 3adult subjects
To determine the safety and tolerability of single doses of inhaled PUR3100 in healthy through the review of AEs
Maximum Plasma Concentration [Cmax]
Time frame: Day 1 through Day 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the maximum drug concentration in blood plasma. This will also be compared to Cmax of participants who receive IV D.H.E. 45.
Last Observed Plasma Concentration [Clast]
Time frame: Day 1 through Day 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the last observed quantifiable concentration of PUR 3100 in blood plasma. This will also be compared to Clast of participants who receive IV D.H.E. 45.
Time to Peak Drug Concentration [Tmax]
Time frame: Day 1 through Day 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time time it takes for a drug to reach the maximum concentration (Cmax). This will also be compared to Tmax of participants who receive IV D.H.E. 45.
Time of last measurable concentration [Tlast]
Time frame: Day 1 through Day 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time time it takes for a drug to reach the last measurable concentration of PUR 3100 in blood plasma. This will also be compared to Tlast of participants who receive IV D.H.E. 45.
Area under the curve [AUC (0-t), AUC (0-inf), AUC (0-2h)]
Time frame: Day 1 through Day 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the drug concentration in blood plasma over time. This will also be compared to the AUC (0-t), AUC (0-inf), and AUC (0-2h) of participants who receive IV D.H.E. 45.
Half Life [ t 1/2 ]
Time frame: Day 1 through 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects by measuring the time it takes for the amount of drug in the blood to reduce by 50%. This will also be compared to the half life of participants who receive IV D.H.E. 45.
Clearance (CL/F)
Time frame: Day 1 through Day 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects. This will also be compared to the CL/F of participants who receive IV D.H.E. 45.
Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time frame: Day 1 through Day 3
To characterize the systemic pharmacokinetics (PK) of single doses of inhaled PUR3100 in healthy adult subjects. This will also be compared to the Vz/F of participants who receive IV D.H.E. 45.
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 23 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 PUR3100 and Dihydroergotamine (D.H.E 45) in people with Healthy, run by Pulmatrix Inc. at 1 site in Australia.
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 13 inclusion and 28 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 23 Dec 2022. 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 Australia. 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?
Safety and Tolerability (time frame: Day 1 through Day 3adult subjects). The study lists 9 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 23 Dec 2022.