AZD2115 Single Ascending Dose Study

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD2115 After Single Ascending Doses in Healthy Male Subjects

AZD2115 Single Ascending Dose Study

Inclusion Criteria:

• Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
• Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the day of dosing until 3 months after dosing with the investigational product.
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
• Be able to inhale from a Spira nebuliser according to given instructions

Exclusion Criteria:

• Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome

• Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:

  • PR (PQ) interval prolongation >200 ms (first degree AV block)
  • Intermittent second or third degree AV block (based on screening or pre-dose ECG)
  • Incomplete, full or intermittent bundle branch block (QRS <110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
  • Abnormal T wave morphology, particularly in the protocol defined primary lead
  • Dropped beats

• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2115 and/or excipients

• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

• Serum potassium concentration of <3.80 mmol/L on admission (Day -1)