This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01030224
• Collaborator: Quintiles, Inc. (Industry)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 3.9
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD9742; Drug: Placebo to match AZD9742	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Single Ascending Doses in Healthy Male and Female Subjects
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD9742 IV Infusion Active	Drug: AZD9742; Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee
Placebo Comparator: Placebo to AZD9742 IV Infusion Placebo	Drug: Placebo to match AZD9742; Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals [Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.]

Secondary Outcome Measures

1. Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine [Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures.

• Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.

• Healthy male and female volunteers. Females must be of non childbearing potential.

Exclusion Criteria:

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product

• History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States

Sponsors and Collaborators

• AstraZeneca
• Quintiles, Inc.

Investigators

• Principal Investigator: Dr. Ralph A Schutz, Quintiles, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01030224
• Other Study ID Numbers: D2690C00001
• First Posted: Dec 11, 2009
• Last Update Posted: Jul 27, 2012
• Last Verified: Mar 1, 2010

• Keywords provided by AstraZeneca: Healthy volunteer; First time in human

Study Results

No Results Posted as of Jul 27, 2012