Healthy
Conditions
Keywords
Healthy volunteers
Brief summary
The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.
Interventions
DRUGAZD5985
Single dose-The starting dose will be 40 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca predefined upper exposure limits
DRUGPlacebo
Oral suspension
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 procedure * Healthy male subjects aged 18 to 45 years (inclusive) * 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 non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start
Exclusion criteria
* History or presence of any clinically significant disease or disorder in the opinion of the investigator * Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator * Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) | Frequent sampling occasions during study days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables | Frequent sampling occasions during study days |
Countries
Sweden
Outcome results
None listed