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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01171105
First received: July 21, 2010
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Multiple-dose PK and dose proportionality [ Time Frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12. ] [ Designated as safety issue: No ]
  • Time to reach steady state [ Time Frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01171105     History of Changes
Other Study ID Numbers: D3030C00002
Study First Received: July 21, 2010
Last Updated: July 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
AZD5213 Phase 1
Safety
tolerability

ClinicalTrials.gov processed this record on October 17, 2012