Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
Study Details
Study Description
Brief Summary
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The main purpose of this study is to assess the safety and tolerability of AZD5213 after multiple oral doses.
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Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 AZD5213 (dose escalating) |
Drug: AZD5213
oral solution, multiple ascending doses
|
| Placebo Comparator: 2 Placebo |
Drug: Placebo to AZD5213
|
Outcome Measures
Primary Outcome Measures
- Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale [Up to 30 days screening period. Residential period will be 14 days. Follow up period will be 7 to 10 days after dose]
Secondary Outcome Measures
- Multiple-dose PK and dose proportionality [Frequent timepoints within 48 hours of multiple dose day 1 and day 12.]
- Time to reach steady state [Frequent timepoints within 48 hours of multiple dose day 1 and day 12.]
- Degree of accumulation and time dependancy of orally-administered AZD5213 [Frequent timepoints within 48 hours of multiple dose day 1 and day 12.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and non-fertile female healthy volunteers aged 18-50 years and 65-80 years inclusive at day of enrollment with suitable veins for cannulation or repeated venipuncture.
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Male healthy volunteers should be willing to use barrier contraception during sexual intercourse, ie condoms, even if partner is using contraceptive method, from the first day of dosing until 3 months after the last dosing with AZD5213.
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Body weight of ≥50 to ≤100 Kg and Body Mass Index (BMI) ≥18 to ≤30 kg/m2.
Exclusion Criteria:
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History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disorders.
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History or presence of gastrointestinal (including irritable bowel disease), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Surgery on gastrointestinal tract.
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History of previous or ongoing psychiatric disorders.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Overland Park | Kansas | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: David Mathews, MD, Quintiles, 6700 W. 115th Street, Overland Park, KS 66211
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- D3030C00002