Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inh… (NCT04903730) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution
Australia83 participantsStarted 2021-05-24
Plain-language summary
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provide written consent.
✓. Body weight ≥ 50 kg, and a body mass index 18.0 to 32.0, inclusive.
✓. Female participants of non child bearing potential or if of child bearing potential, agrees to take effective contraceptive measures throughout the study period.
✓. Male participant: has undergone bilateral vasectomy or agrees to use effective contraceptive effective contraceptive measures or abstinence, and not donate sperm throughout the study until at least 3 months after the last dose of IP.
✓. Forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio of at least 0.7.
✓. Values for FEV1 and FVC of at least 80% of the predicted value.
✓. Able to understand the nature of the study and any hazards of participation, and ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire study.
✓. Able to successfully perform spirometry and use the inhalation device at Screening.
Exclusion criteria
✕. Clinically significant physical findings, vital signs, ECG, or laboratory values that could interfere with the objectives of the study or the safety of the subject.
✕. Pregnant or lactating or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
✕
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timeframe: From randomization though study completion (up to 17 days following last treatment)
2
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From randomization though study completion (up to 17 days following last treatment)
. Presence of acute or chronic illness or history of chronic illness.
✕. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary artery disease, or history of any psychotic mental illness.
✕. Upper or lower respiratory tract infection within 4 weeks before the first dose of treatment.
✕. Any medically identified respiratory disease(s) and/or condition(s), including but not limited to current asthma, chronic obstructive pulmonary disease, and diagnosed obstructive sleep apnoea syndrome.
✕. Any clinically significant arrhythmia(s) at Screening ECG.
✕. History of surgery or medical intervention, or planned surgery or medical intervention, that could interfere with the objectives of the study or the safety of the volunteer.