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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171105
First Posted: July 28, 2010
Last Update Posted: January 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
  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
Placebo
Drug: Placebo to AZD5213

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171105


Locations
United States, Kansas
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
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01171105     History of Changes
Other Study ID Numbers: D3030C00002
First Submitted: July 21, 2010
First Posted: July 28, 2010
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by AstraZeneca:
AZD5213 Phase 1
Safety
tolerability