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

NCT01171105 | Completed Phase 1 DMC

• 1 other identifier: D3030C00002
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

AZD5213 Phase 1; Safety; tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

1

EXPERIMENTAL

AZD5213 (dose escalating)

Drug: AZD5213

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo to AZD5213

Interventions

AZD5213 DRUG

oral solution, multiple ascending doses

1

Placebo to AZD5213 DRUG

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Links

• D3030C00002 Clinical Study Report Synopsis

Study Officials

• David Mathews, MD

  Quintiles, 6700 W. 115th Street, Overland Park, KS 66211

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

US (1)