Single ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD4451 - AZD4451 SAD

Study identifier:D3600C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomized, Double- blind, Placebo- controlled, Single-center Study, to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451 Following Single Ascending Oral Dose Administration in Healthy Subjects

Medical condition

Bipolar Disorder

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4451, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Aug 2010

Primary Completion Date: 01 Apr 2011

Study Completion Date: 01 Apr 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Other

Verification:

Verified 01 Jul 2011 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Provide a signed and dated, written informed consent prior to any study specific procedures being performed. including the genetic sampling and analyses. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer. The volunteer will not be excluded from other aspects of the study described in this protocol.
- Healthy male and female (of non-childbearing potential) volunteers 18 to 55 years old inclusive with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be nursing and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Post-menopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and with FSH levels in the laboratory defined post-menopausal range
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
Male volunteers should be willing to use barrier contraception for example, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product.
- Have a body mass index (BMI) between 19 and 30 kg/m2 (BMI <30.5 =30) and weigh at least 50 kg and no more than 100 kg inclusive.

Exclusion Criteria

- History of gastrointestinal surgery (other than cholecystectomy or appendectomy) or unintentional rapid weight loss.
- A positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
- History of any of the following as judged by the Investigator: History of psychiatric disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders text revision; Medically diagnosed depression in the 6 months prior to dosing; Bipolar disorder; Use of psychoactive medication (including mood stabilizers) in the 6 months prior to dosing; Electroconvulsive therapy in the 6 months prior to dosing; History of seizures 1 year prior to dosing; History of severe dystonic reaction to other drugs.
- History of syncope, fainting or of vasovagal reactions; history of arrhythmias, and/or postural hypotension. The inclusion of volunteers meeting the above criteria may be decided on a case-by-case basis after consultation between the Investigator and AZ CPA physician.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.

No locations available

Arms	Assigned Interventions
Experimental: 1 AZD4451	Drug: AZD4451 1 mg capsules, 5 mg capsules, and 25 mg capsules
Placebo Comparator: 2 Placebo	Drug: Placebo 1 mg capsules, 5 mg capsules, and 25 mg capsules

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Quintiles Overland Park (QOPK) Kansas, USA

1-800-292-5533

[email protected]

Investigators

Principal Investigator

Mark Smith

AstraZeneca, LP, 1800 Concord Pike, Wilmington, DE