Clinical trial NCT01171105: Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
Official title: A Phase I, Double-blind, Randomized, Placebo-controlled', Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD5213 After Administration of Multiple Ascending Doses for 10 Days in Healthy Male and Non-fertile Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD5213 Phase 1
Safety
tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after multiple oral doses.
2. 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.
* Body weight of ≥50 to ≤100 Kg and Body Mass Index (BMI) ≥18 to ≤30 kg/m2.

Exclusion Criteria:

* History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disorders.
* 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.
* History of previous or ongoing psychiatric disorders.

Primary outcomes:
measure: 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
timeFrame: Up to 30 days screening period. Residential period will be 14 days. Follow up period will be 7 to 10 days after dose
Secondary outcomes:
measure: Multiple-dose PK and dose proportionality
timeFrame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
measure: Time to reach steady state
timeFrame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
measure: Degree of accumulation and time dependancy of orally-administered AZD5213
timeFrame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles, 6700 W. 115th Street, Overland Park, KS 66211
name: David Mathews, MD
role: PRINCIPAL_INVESTIGATOR
References: