HealthyPhase 1NCT04872231
Single Ascending Dose and Multiple Ascending Dose Study of Voriconazole Inhalation Powder in Healthy Adult Subjects
A Phase 1 study testing Voriconazole Inhalation Powder in people with Healthy, run by TFF Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of Voriconazole Inhalation Powder versus placebo (SAD part) and escalating multiple doses of Voriconazole Inhalation Powder versus… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Voriconazole Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2019to 26 Aug 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent to participate.
- Healthy, adult males or females (women of non-childbearing potential only).
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
- Medically healthy with no clinically significant abnormalities in medical history, physical and visual examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- Agree to abstain from recreational drug use throughout the study.
- Must be willing and able to comply with the protocol.
- Succeed in training on the use of the device for maximum of 12 inhalations in total, with demonstration of at-least 8 successful inhalations of empty capsules during training.
- Have had a forced expiratory volume in one second (FEV1) ≥80%.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems in the opinion of the PI.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years.
- History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or any triazole antifungal.
- Has had surgery or any medical condition within 6 months prior to first dosing which may affect the absorption, distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.
Show all 26Show fewer
- Female subjects of childbearing potential.
- Female subjects with a positive pregnancy test or who are lactating.
- Positive urine drug or alcohol results at screening or first check-in.
- Positive cotinine results at screening.
- Diagnosis of asthma.
- Use of albuterol or a similar bronchodilator
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- QTcF interval is >450 msec or has ECG findings deemed abnormal with clinical significance by the PI at screening.
- Seated blood pressure with systolic less than 90 mmHg or diastolic less than 60 mm/Hg or with a systolic greater than 140 mmHg or diastolic greater than 90 mmHg at screening.
- Seated heart rate is lower than 60 bpm or higher than 100 bpm at screening.
- Using any exclusionary medication.
- Donation or loss of 50 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Has coagulation test outside of normal ranges.
- Has platelet, hemoglobin, and hematocrit that are below the lower limit of normal.
- Has liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALP and total bilirubin that are greater than the upper limit of normal. Estimated creatinine clearance <90 mL/min at screening.
- Participation in another clinical study within 30 days prior to the first dosing.
- Had a treatment with other investigational drug within 5 times the elimination half- life, if known (e.g., a marketed product) or within 30 days (if the elimination half-life is unknown) prior to first dosing.
- Demonstrates an inability to operate the inhalation device after training.
- Allergy or sensitivity to lactose or milk products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Single-Dose and Multiple Dose Dose-Ranging Study of Voriconazole Inhalation Powder in Healthy Adult Subjects
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of Voriconazole Inhalation Powder versus placebo (SAD part) and escalating multiple doses of Voriconazole Inhalation Powder versus placebo (MAD part). SAD part will be initiated first and includes a sentinel design. MAD part will not utilize a sentinel design and will be initiated once the lowest doses from SAD part are deemed safe.
Read the detailed description
This is a Phase 1, randomized, 2 part double-blind, placebo-controlled trial to evaluate the safety and PK profiles of Voriconazole Inhalation Powder (VIP) in a SAD/MAD study design.
Part A is a double-blinded, placebo-controlled, randomized, dose- ranging single dose study evaluating four different dose levels.
On Day 1 of each group, two selected subjects (sentinel subjects) will receive either Voriconazole Inhalation Powder or a matching placebo. Blood and sputum samples and safety measurements including Adverse Events (AEs) will be collected over 24 hour period following the drug administration. The safety results to be evaluated include AEs, concomitant medications, out of specification clinical laboratory results, vital signs, Electrocardiograms (ECGs), visual examinations, pulmonary function tests, pulse oximetry results and any new findings on physical examinations. If the administration is safe as deemed by Principal Investigator \& Medical Monitor, the remaining six subjects will be dosed, with identical safety and PK procedures performed after minimum of 3 days interval. A minimum of 3 days will separate each dose escalation, with the remaining dose groups dosed in a sentinel fashion.
Part B is a double-blinded, placebo-controlled, randomized, dose- ranging multi-dose study evaluating four different dose levels. Dose level 1 of Part B can begin in parallel once safety assessments of Part A dose level 2 are complete and indicate safety is present. Voriconazole Inhalation Powder will be administered twice daily (BID) × 13 doses. Blood samples for safety and PK will be collected over 12 hours after the first dose and 24 hours after the last dose. A minimum of 1 week will separate the start of each dose escalation, with the remaining dose groups.
- Conditions
- Healthy
- Being tested
- Voriconazole Inhalation Powder, Placebo
- Keywords
- voriconazole, inhaled, VFEND, aspergillosis, IPA, fungal infection, pulmonary aspergillosis
- Medical subject headings
- Respiratory Aspiration, Aspergillosis, Mycoses, Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole Inhalation PowderDrug
Also called VIP
PART A (SAD): Voriconazole Inhalation Powder (VIP) will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period.
SAD subjects will receive a single dose of study medication. Subjects in Cohort 1 will receive 10 mg, Cohort 2: 20 mg, Cohort 3: 40 mg, Cohort 4: 80 mg.
PART B (MAD): Voriconazole Inhalation Powder (VIP) and will be administered with a will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period.
MAD subjects will receive VIP BID for a total of 13 doses. Subjects in Cohort 1 will receive 10 mg BID, Cohort 2: 20 mg BID, Cohort 3: 40 mg BID, Cohort 4: 80 mg BID.
PlaceboDrug
Also called Vehicle
PART A (SAD): Placebo capsules will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period.
Subjects in PART A will receive a single dose of placebo.
PART B (MAD): Placebo will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period.
Subjects in PART B will receive Placebo BID for a total of 13 doses.
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole Inhalation Powder | Experimental | Investigational drug will be supplied as capsules, each capsule contains 10 mg of Voriconazole Inhalation Powder. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. Receives: Drug: Voriconazole Inhalation Powder |
| Placebo | Placebo comparator | Placebo will be supplied as capsules, each capsule will contain no active ingredient. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs
Number of AEs, SAEs, and discontinuations due to AEs
Measured: Through study completion, an average of 14 days
Number of participants who experience vital sign abnormalities
Number of participants with potentially clinically significant vital sign values
Measured: Baseline through study completion, an average of 14 days
Number of participants who experience pulse oximetry abnormalities
Number of participants with potentially clinically significant pulse oximetry values
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in forced expiratory volume (FEV1)
Spirometry used to measure FEV1 lung function
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in forced vital capacity (FVC)
Spirometry used to measure FVC lung function
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in FEV1/FVC ratio
Spirometry used to measure FEV1 and FVC lung function
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in QTcF changes via ECG
Number of participants with potentially clinically significant ECG values
Measured: Baseline through study completion, an average of 14 days
Number of participants who experience physical examination abnormalities
Number of participants with potentially clinically significant physical examination findings
Measured: Baseline through study completion, an average of 14 days
Number of participants who experience laboratory test abnormalities
Number of participants with potentially clinically significant laboratory test results
Measured: Baseline through study completion, an average of 14 days
PK of VIP in plasma: Area under the plasma-concentration time curve (AUC)
Blood samples will be collected for plasma analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Maximum observed concentration (Cmax)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Time to maximal observed concentration (tmax)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Termination elimination half-life (t½)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Apparent total body clearance (CL/F)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
PK of VIP in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start22 Nov 2019
- Primary completion29 Jul 2020
- Study completion26 Aug 2020
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A: Eight (8) subjects will participate in each of the 4 dose escalations. Subjects will be randomized to receive either Voriconazole Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8). Part B: Eight (8) subjects will participate in each of the 4 dose escalations. Subjects will be randomized to receive either Voriconazole Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- TFF Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dale Christensen, PhD, Study director, TFF Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872231
- Sponsor's protocol ID
- TFF-V1-001
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Single-Dose and Multiple Dose Dose-Ranging Study of Voriconazole Inhalation Powder in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04872231
- Acronym / sponsor ID
- TFF-V1-001
- Conditions
- Healthy
- Keywords
- voriconazole, inhaled, VFEND, aspergillosis, IPA, fungal infection, pulmonary aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- TFF Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 4 May 2021 (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.
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of Voriconazole Inhalation Powder versus placebo (SAD part) and escalating multiple doses of Voriconazole Inhalation Powder versus placebo (MAD part). SAD part will be initiated first and includes a sentinel design. MAD part will not utilize a sentinel design and will be initiated once the lowest doses from SAD part are deemed safe.
Detailed description
This is a Phase 1, randomized, 2 part double-blind, placebo-controlled trial to evaluate the safety and PK profiles of Voriconazole Inhalation Powder (VIP) in a SAD/MAD study design.
Part A is a double-blinded, placebo-controlled, randomized, dose- ranging single dose study evaluating four different dose levels.
On Day 1 of each group, two selected subjects (sentinel subjects) will receive either Voriconazole Inhalation Powder or a matching placebo. Blood and sputum samples and safety measurements including Adverse Events (AEs) will be collected over 24 hour period following the drug administration. The safety results to be evaluated include AEs, concomitant medications, out of specification clinical laboratory results, vital signs, Electrocardiograms (ECGs), visual examinations, pulmonary function tests, pulse oximetry results and any new findings on physical examinations. If the administration is safe as deemed by Principal Investigator \& Medical Monitor, the remaining six subjects will be dosed, with identical safety and PK procedures performed after minimum of 3 days interval. A minimum of 3 days will separate each dose escalation, with the remaining dose groups dosed in a sentinel fashion.
Part B is a double-blinded, placebo-controlled, randomized, dose- ranging multi-dose study evaluating four different dose levels. Dose level 1 of Part B can begin in parallel once safety assessments of Part A dose level 2 are complete and indicate safety is present. Voriconazole Inhalation Powder will be administered twice daily (BID) × 13 doses. Blood samples for safety and PK will be collected over 12 hours after the first dose and 24 hours after the last dose. A minimum of 1 week will separate the start of each dose escalation, with the remaining dose groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part A: Eight (8) subjects will participate in each of the 4 dose escalations. Subjects will be randomized to receive either Voriconazole Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8). Part B: Eight (8) subjects will participate in each of the 4 dose escalations. Subjects will be randomized to receive either Voriconazole Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8).
| Arm | Type | Receives |
|---|---|---|
| Voriconazole Inhalation Powder | Experimental | Drug: Voriconazole Inhalation PowderInvestigational drug will be supplied as capsules, each capsule contains 10 mg of Voriconazole Inhalation Powder. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be supplied as capsules, each capsule will contain no active ingredient. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provide written informed consent to participate.
- Healthy, adult males or females (women of non-childbearing potential only).
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
- Medically healthy with no clinically significant abnormalities in medical history, physical and visual examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- Agree to abstain from recreational drug use throughout the study.
Key exclusion criteria (26 listed)
- Is mentally or legally incapacitated or has significant emotional problems in the opinion of the PI.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years.
- History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or any triazole antifungal.
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 |
|---|---|---|
| Voriconazole Inhalation PowderAlso: VIPPART A (SAD): Voriconazole Inhalation Powder (VIP) will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period. SAD subjects will receive a single dose of study medication. Subjects in Cohort 1 will receive 10 mg, Cohort 2: 20 mg, Cohort 3: 40 mg, Cohort 4: 80 mg. PART B (MAD): Voriconazole Inhalation Powder (VIP) and will be administered with a will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period. MAD subjects will receive VIP BID for a total of 13 doses. Subjects in Cohort 1 will receive 10 mg BID, Cohort 2: 20 mg BID, Cohort 3: 40 mg BID, Cohort 4: 80 mg BID. | Drug | Voriconazole Inhalation Powder |
| PlaceboAlso: VehiclePART A (SAD): Placebo capsules will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period. Subjects in PART A will receive a single dose of placebo. PART B (MAD): Placebo will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period. Subjects in PART B will receive Placebo BID for a total of 13 doses. | Drug | Placebo |
Primary outcome
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs
Time frame: Through study completion, an average of 14 days
Number of AEs, SAEs, and discontinuations due to AEs
Number of participants who experience vital sign abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant vital sign values
Number of participants who experience pulse oximetry abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant pulse oximetry values
Mean change from baseline in forced expiratory volume (FEV1)
Time frame: Baseline through study completion, an average of 14 days
Spirometry used to measure FEV1 lung function
Mean change from baseline in forced vital capacity (FVC)
Time frame: Baseline through study completion, an average of 14 days
Spirometry used to measure FVC lung function
Mean change from baseline in FEV1/FVC ratio
Time frame: Baseline through study completion, an average of 14 days
Spirometry used to measure FEV1 and FVC lung function
Mean change from baseline in QTcF changes via ECG
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant ECG values
Number of participants who experience physical examination abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant physical examination findings
Number of participants who experience laboratory test abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant laboratory test results
PK of VIP in plasma: Area under the plasma-concentration time curve (AUC)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for plasma analysis
PK of VIP in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
PK of VIP in plasma: Maximum observed concentration (Cmax)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
PK of VIP in plasma: Time to maximal observed concentration (tmax)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
PK of VIP in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
PK of VIP in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
PK of VIP in plasma: Termination elimination half-life (t½)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
PK of VIP in plasma: Apparent total body clearance (CL/F)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
PK of VIP in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: Predose Day 1 and through 12 hours post last dose (day 6)
Blood samples will be collected for analysis
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 6 May 2021.
- 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.
Dale Christensen, PhD study director
TFF Pharmaceuticals
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 Voriconazole Inhalation Powder in people with Healthy, run by TFF Pharmaceuticals, Inc. at 1 site in Canada.
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 8 inclusion and 26 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 6 May 2021. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs (time frame: Through study completion, an average of 14 days). The study lists 18 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 6 May 2021.