Status:
COMPLETED
AZD2115 Multiple Ascending Dose Study
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This study will investigate the safety and tolerability of AZD2115 following administration of multiple ascending doses.
Detailed Description
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Dos...
Eligibility Criteria
Inclusion
- 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 and spermicide, from the day of first administration of the AZD2115 until 3 months after administration and must not donate sperm for 3 months after follow-up
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Exclusion
- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
- Systolic BP \>140 mmHg
- Diastolic BP \>90 mmHg
- Heart rate \<40 or \>85 bpm
- Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
- Serum potassium concentration of \< 3.80 mmol/L on admission (Day -1)
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with the same class to AZD2115 or to excipients
- History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01445782
Start Date
October 1 2011
End Date
July 1 2012
Last Update
October 8 2012
Active Locations (1)
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1
Research Site
London, UK, United Kingdom