AZD8075 Single Ascending Dose Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00787072

Purpose

The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

Condition	Intervention	Phase
Healthy Volunteers	Drug: AZD8075 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Official Title:	A Phase I, Single Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK variables [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD8075 Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.
2: Placebo Comparator	Drug: Placebo Oral suspension

Eligibility

Criteria

Inclusion Criteria:

Provision of signed, written and dated informed consent prior to any study specific procedures.
Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

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 relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787072

Contacts

Contact: Phase I Services Quintiles AB	46 18 431 10 00	louise.lunt@quintiles.com
Contact: AstraZeneca Clincial Study Information	800-236-9933	information.center@astrazeneca.com

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Eva Pettersson	AstraZeneca R&D, Lund, Sweden
Principal Investigator:	Wolfgang Kühn	Quintiles, Uppsala, Sweden

More Information

Responsible Party:	AstraZeneca R&D Lund, Sweden ( Christer Hultquist, Medical Science Director )
Study ID Numbers:	D3801C00001
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787072
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009