PET Study to Determine Muscarinic Receptor Occupancy in Lungs After Inhalation of AZD2115 and Tio… (NCT03097380) | Clinical Trial Compass
CompletedPhase 1
PET Study to Determine Muscarinic Receptor Occupancy in Lungs After Inhalation of AZD2115 and Tiotropium
Sweden19 participantsStarted 2017-04-26
Plain-language summary
An open-label study using positionemissiontomography (PET) to explore the binding of AZD2115 and Tiotropium to muscarinic receptors in the lungs in healthy volunteers after inhalation.
Who can participate
Age range20 Years – 50 Years
SexMALE
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Inclusion Criteria:
* Provision of signed and dated written informed consent prior to any study specific procedures
* Healthy male subjects, aged 20 to 50 years (inclusive)
* Male subjects must be surgically sterile or use an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the first dose) and for 3 months after the last dose of study drug to prevent pregnancy in a partner
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least 50.0 kg and no more than 100.0 kg, inclusive
* Able and willing to participate in all scheduled evaluations and abide by all study restrictions
* Ability to inhale from the study drug training devices at visit 1
* Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug.
Exclusion Criteria:
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the study results or the subject's ability to participate in the study.
* Any clinical significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP)
* Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator.
* Any positive results on screening for…