Status and phase
Conditions
Treatments
About
This is a three part, randomized, open-label, crossover, Phase 1 trial in adults. Parts 1 and 2 will enroll healthy male and female subjects. Part 3 will enroll subjects with mild asthma. This study will assess the pharmacokinetics, safety and tolerability of single doses of budesonide delivered by VR647 Inhalation System (AKITA® JET) with mouthpiece or face mask to single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS®) with mouthpiece or face mask.
Full description
For all parts of the study, subjects in the VR647 group will receive VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) with either a mouthpiece or a facemask. Similarly, for all parts of the study, subjects in the comparator group will receive approved doses of budesonide (Pulmicort Respules®) delivered by a conventional jet nebulizer (PARI VIOS) with either a mouthpiece or a facemask.
Part 1:
Subjects who fulfill the enrollment criteria will progress to a comparative single dose, 6-treatment, 6-period crossover trial. Subjects will receive 4 dose levels of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) (5, 10, 15 and 25 breaths, with targeted doses of 30, 60, 120 and 240 µg) and 2 dose levels of budesonide delivered by a conventional jet nebulizer (PARI VIOS) (0.5 and 1 mg). There will be a Washout Period between each dose of approximately 48 hours. Each subject will be randomized to treatment.
Part 2:
Following an approximate 7-day washout, the same cohort of subjects from Part 1 will progress to a comparative single dose, 6-treatment, 6-period crossover trial. There will be a Washout Period between each dose of approximately 48 hours. Each subject will be randomized to treatment in a 6-way crossover.
Part 3:
Subjects with mild asthma who fulfill the enrollment criteria (including those criteria specific to Part 3) will progress to a comparative single dose, 4-treatment, 4-period crossover trial conducted at a separate clinic from Parts 1 and 2. There will be a Washout Period between each dose of approximately 48 hours. This part of the trial can start before completion of Parts 1 and 2.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female subject
Female subjects must have a negative pregnancy test at the Screening and Day -1 Visits (prior to dosing), must be using a reliable form of contraception throughout the trial, or must be of non-childbearing potential as follows:
Aged 18 to 55 years
Hemoglobin level of ≥11.5 g/dL for females and ≥13.0 g/dL for males
Weigh at least 50 kg, and body mass index (Quetelet index) in the range 18.0-32.0 kg/m2, inclusive
Forced expiratory volume in 1 second (FEV1) of more than 1.69 L at the Screening Visit
Ability to comprehend the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial
Give written consent to participate after reading the consent form, and after having the opportunity to discuss the trial with the investigator or his/her delegate
Additional Inclusion Criteria for Part 3:
Exclusion criteria
Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the subject (excluding mild asthma in Part 3)
Subjects who have impaired cardiovascular, endocrine, autoimmune, metabolic, neurological, renal, respiratory (excluding mild asthma in Part 3), gastrointestinal, hepatic, hematological or any other system abnormalities
Respiratory tract infection within 4 weeks before the Screening Visit
History of surgery or medical intervention within 6 weeks before the Screening Visit, or planned surgery or medical intervention, that could interfere with the objectives of the trial or the safety of the subject
Regular treatment (more than 1 month duration) with oral or parenteral corticosteroids in the last year prior to the Screening Visit
Use of the following prescription medications within 28 days prior to the first dose:
Presence or history of severe adverse reaction to any drug, or sensitivity to components of the trial medication
Use of a prescription or over-the-counter medicine, nutritional and vitamin supplements, with the exception of acetaminophen and hormonal contraceptives, during the 7 days before the first dose of trial medication. For Part 3 only, inhaled short-acting β2-agonists in addition to acetaminophen and hormonal contraceptives are permitted
Participation in another clinical trial of a new chemical entity, new device, or a prescription medicine within the 3 months before dosing, or participation within 5 half-lives of receiving an experimental drug (whichever is longer)
Presence or history of drug or alcohol abuse, or intake of more than 21 units (14 units for women) of alcohol weekly
Evidence of drug abuse on urine testing, or a positive test for alcohol
Current smoker; or ex-smokers who (a) gave up less than 1 year ago, or (b) who have a history of more than 10 pack years. A pack year is calculated as the number of cigarettes per day multiplied by number of years smoked divided by 20
Blood pressure and heart rate at the screening examination outside the ranges 90-140 mmHg systolic, 40-90 mm Hg diastolic, heart rate 40-100 beats/min
Loss of more than 400 mL blood, e.g., as a blood donor, or donation of blood products, during the 3 months before the Screening Visit
Positive test for hepatitis B, hepatitis C, or HIV
History of, or latent, tuberculosis (TB) infection
Evidence of any other clinically significant infection, including bacterial or viral infections
Possibility that the subject will not cooperate with the requirements of the protocol, including effective use of the nebulizer
Employee of the investigational site or the Sponsor, who is directly involved in the trial, or a family member of such a person
Additional Exclusion Criteria for Part 3:
Primary purpose
Allocation
Interventional model
Masking
34 participants in 16 patient groups
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Data sourced from clinicaltrials.gov
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