AZD8075 Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

This study has been terminated.

( Due to termination of study D3801C00001, due to reports of turbid urine. )

First Received: January 20, 2009 Last Updated: April 10, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00829127

Purpose

The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days

Condition	Intervention	Phase
Healthy	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 Multiple 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: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

characterise the multiple dose PK of AZD8075 and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK [ Time Frame: daily ] [ Designated as safety issue: No ]

Estimated Enrollment:	27
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD8075 single dose, oral suspension, on Day 1. Repeated dosing will commence on Day 3 once daily for 14 days. The planned starting dose will be 35 mg with up to 2 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits or the exposure obtained so far in the SAD study.
2: Placebo Comparator	Drug: Placebo Oral suspension

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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 phys.examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
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: NCT00829127

Locations

Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Responsible Party:	AstraZeneca ( Christer Hultquist, Medical Science Director )
Study ID Numbers:	D3801C00004, EudraCt No.2008-006550-17
Study First Received:	January 20, 2009
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00829127 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 10, 2009