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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD8075; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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.
Placebo Comparator: 2	Drug: Placebo; Oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	daily

Secondary Outcome Measures

Outcome Measure	Time Frame
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	daily

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): January 1, 2009
• Study Completion (Anticipated): January 1, 2009

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): August 25, 2011
• Last Update Submitted That Met QC Criteria: August 24, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: volunteers
• Other Study ID Numbers: D3801C00004; EudraCt No.2008-006550-17