Status:
COMPLETED
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Inhaled AZD8683
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing single doses of AZD8683 administered via inhalation
Detailed Description
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of inhaled AZD8683 after Single A...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures Healthy male subjects aged 18
- 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 dosing until at least 3 months after dosing with the investigational product
- Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive
Exclusion
- 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
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
- Systolic blood pressure \>140 mm Hg
- Diastolic blood pressure \>90 mm Hg
- Heart rate \<40 or \>85 beats per minute Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG. This includes subjects with any of the following:
- PR(PQ) interval prolongation \>200 ms or dropped beats (single non conducted P-waves) based on screening or Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01419600
Start Date
October 1 2011
End Date
May 1 2012
Last Update
July 3 2012
Active Locations (1)
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1
Research Site
London, UK, United Kingdom