Healthy
Conditions
Brief summary
This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.
Interventions
DRUGAZD7295
Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.
DRUGPlacebo comparator
Placebo capsules
Sponsors
Arrow Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female volunteers, aged 18-65 years.
Exclusion criteria
* Previous exposure to AZD7295, clinically relevant disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of AZD7295 capsules | 0-72h after each dose | PK parameters of AZD7295 will be measured after single and repeated doses (AUC, Cmax, t1/2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of AZD7295 capsules | 0-72h after each dose | Safety and tolerability of AZD7295 will be assessed after single and repeated doses (adverse events, ECGs, vital signs, safety laboratory tests) |
Countries
United Kingdom
Outcome results
None listed