Study identifier:D3340C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Single-centre Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Dose, Parallel-group Study to Determine the Safety, Tolerability, and Pharmacokinetics of AZD4316 in Healthy Volunteers
Healthy Volunteers
Phase 1
Yes
AZD4316
All
128
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Nov 2010 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Part A: single ascending dose AZD4316: single oral dose, with 1 group with/without food | Drug: AZD4316 Single oral doses of AZD4316 suspension in the fasted state. In one group in Part A, subjects will receive a second dose of AZD4316 in the fed state (within 30 min after receiving a high fat breakfast) Other: Placebo Placebo to match AZD4316 |
Placebo Comparator: Part B: multiple ascending dose AZD4316: multiple oral doses | Drug: AZD4316 Multiple oral doses of AZD4316 suspension. It’s planned that doses will be administered in the fasted state, however, if in Part A it’s shown that food increases absorption of AZD4316, then doses will be administered after a meal. Other: Placebo Placebo to match AZD4316 |