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

NCT01121302 | Completed Phase 1 DMC

• 1 other identifier: D3030C00001
• Study Type: interventional
• Target: 88
• 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 single 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

Tolerability

Keywords

AZD5213; Phase 1; Safety

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

  AE will be collected from admission on Day -1 until follow-up

Secondary Outcomes (2)

• Part 1 : Investigate single-dose PK and dose proportionality of orally-administered AZD5213

  Frequent timepoints within 48 hours of single dose administration

• Part 2 Investigate the potential effect of food on AZD5213 PK after administration of AZD5213 as an oral solution

  Frequent timepoints after volunteer consumes a high fat, high calorie breakfast, per FDA guidelines.

Study Arms (2)

1

EXPERIMENTAL

dose escalating

Drug: AZD5213

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

AZD5213 DRUG

0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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, gastorintestinal 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

• D3030C00001 Clinical Study Report Synopsis

Study Officials

• David Mathews, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

US (1)