Healthy
Conditions
Keywords
Healthy volunteers
Brief summary
The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers
Interventions
DRUGAZD5985
Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined 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 procedures. * Healthy male subjects aged 18 to 45 years (inclusive). * Have a body mass index (BMI) between 19 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 method development study (no drug) 1 month prior to Visit 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985. | Frequent sampling occasions during study days |
Countries
Germany
Outcome results
None listed