Healthy
Conditions
Keywords
Phase 1, healthy volunteer, male, pharmacokinetics, AZD1305
Brief summary
The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.
Interventions
DRUGAZD1305
Single Oral Dose, ER formulation 1
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed, written and dated informed consent prior to any study specific procedures. * Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Exclusion criteria
* History or presence of any clinically significant disease or disorder in the opinion of the investigator. * Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit. * Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma | From predose until 48 hours post last dose |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight | Frequent safety measurements during the study, from screening period to follow-up |
Countries
United Kingdom
Outcome results
None listed