Safety, Tolerability and Pharmacokinetics of PUR1900 (Itraconazole Powder) in Healthy Volunteers … (NCT03479411) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetics of PUR1900 (Itraconazole Powder) in Healthy Volunteers and Adults With Asthma
United Kingdom58 participantsStarted 2018-02-09
Plain-language summary
Phase 1, 3-part study to assess safety, tolerability and PK of single and multiple doses of itraconazole administered as a dry powder for inhalation (PUR1900) in healthy subjects (parts 1 and 2) and a 2-period crossover study of single doses of itraconazole administered as a dry powder for inhalation (PUR1900) and an oral solution (Sporanox) in adults with mild to moderate, stable asthma (part 3)
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Healthy males or non-pregnant, non-lactating healthy females.
✓. Age 18 to 60 years
✓. Screening forced expiratory volume in 1 sec (FEV1) ≥80% of the predicted value
✓. Able to demonstrate the correct inhalation technique for use of delivery device during the study.
✓. Males or non-pregnant, non-lactating females with a physician-confirmed diagnosis of asthma for at least 3 months. Asthma must be assessed by investigator as being stable for at least 4 weeks prior to screening.
✓. Age 18 to 60 years
✓. Subject is being treated with either inhaled corticosteroids (ICS) or inhaled corticosteroids plus long-acting beta-agonists (ICS/LABA). Only GINA STEP 2 and 3 patients will be enrolled.
Exclusion criteria
✕. Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing on this study
✕. Subjects who have previously received IMP in this study. Subjects who have participated in Part 1 are not permitted to participate in Part 2 or Part 3.
✕. History of any drug or alcohol abuse in the past 2 years prior to screening.
✕. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
What they're measuring
1
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
Timeframe: Part 1: Baseline through Day 14, Part 2 and 3: Baseline through Day 28
✕. Females of childbearing potential who are pregnant or lactating, or who plan to become pregnant during the study (all female subjects must have a negative pregnancy test at screening). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or is postmenopausal (had no menses for 12 months without an alternative medical cause (will be re-assessed at admission/pre-dose).
✕. Positive drugs of abuse test result at screening or admission
✕. Subjects with congestive heart failure or a history of congestive heart failure
✕. History of severe cough or bronchospasm upon inhalation of any dry powder inhalation product