Healthy
Conditions
Keywords
First in human, Safety
Brief summary
This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied. The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.
Interventions
DRUGAZD7687
Single oral dose
DRUGPlacebo
Single oral dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * BMI between 19-30
Exclusion criteria
* No blood donation prior 30 days * No other clinical study prior 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments) | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters. | — |
| Exploratory pharmacogenetic blood sampling. | — |
| Pharmacodynamic biomarker sampling; blood samples. | — |
Countries
United States
Outcome results
None listed