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Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 21, 2010
Last updated: January 27, 2015
Last verified: January 2015
  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.

Condition Intervention Phase
Healthy Drug: AZD5213 Drug: Placebo to AZD5213 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by AstraZeneca:

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 [ Time Frame: 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 [ Time Frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12. ]
  • Time to reach steady state [ Time Frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12. ]
  • Degree of accumulation and time dependancy of orally-administered AZD5213 [ Time Frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12. ]

Enrollment: 73
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD5213 (dose escalating)
Drug: AZD5213
oral solution, multiple ascending doses
Placebo Comparator: 2
Drug: Placebo to AZD5213


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01171105

United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Principal Investigator: David Mathews, MD Quintiles, 6700 W. 115th Street, Overland Park, KS 66211
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01171105     History of Changes
Other Study ID Numbers: D3030C00002
Study First Received: July 21, 2010
Last Updated: January 27, 2015

Keywords provided by AstraZeneca:
AZD5213 Phase 1
tolerability processed this record on September 21, 2017