A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00935662
• Collaborator: (none)
• Enrollment: 119
• Locations: 2
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 59.5
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Condition or Disease	Intervention/Treatment	Phase
Healthy Men	Drug: AZD8329; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD8329 AZD8329 oral solution	Drug: AZD8329; Oral solution, single ascending doses
Placebo Comparator: Placebo Placebo for AZD8329 oral solution	Drug: Placebo; Oral solution, placebo

Outcome Measures

Primary Outcome Measures

1. Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) [Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.]

Secondary Outcome Measures

1. PK samples for AZD8329 [Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures

• Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

• Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate

• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Linköping		Sweden
2	Research Site	Uppsala		Sweden

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Wolfgang Kühn, Quintiles AB, Phase I Services, Uppsala, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00935662
• Other Study ID Numbers: D2350C00001; EudraCT No. 2009-010702-11
• First Posted: Jul 9, 2009
• Last Update Posted: Sep 13, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: First time in man; Safety study; AZD8329

Study Results

No Results Posted as of Sep 13, 2010