JSAD: AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00912353
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD7268; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: A Phase I, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 in Healthy Japanese Subjects
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD7268	Drug: AZD7268; Single Oral
Placebo Comparator: Placebo	Drug: Placebo; Single Oral

Outcome Measures

Primary Outcome Measures

1. To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings, [From screening period to follow-up, 44 days (maiximum).]

Secondary Outcome Measures

1. To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine. [Blood and urine sampling from pre-dose until 72 hrs post dose.]

2. To collect and store DNA for future exploratory research [One blood sampling after randomisation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive

• Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)

• 18 to ≤ 27 kg/m2

Exclusion Criteria:

• Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study

• Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor

• Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Gelndale	California	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Mark Yen, MD, California Clinical Trials

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00912353
• Other Study ID Numbers: D1151C00002
• First Posted: Jun 3, 2009
• Last Update Posted: Jan 29, 2013
• Last Verified: Aug 1, 2010

• Keywords provided by AstraZeneca: Phase I; Japanese healthy volunteer; AZD7268

Study Results

No Results Posted as of Jan 29, 2013