Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD4017; Drug: Placebo

• Registration Number: NCT00799747
• Lead Sponsor: AstraZeneca

Brief Summary

The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-28
• Study Start: 2008-12
• Study First Posted: 2008-12-01
• Study Completion: 2009-04
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-30
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

Inclusion Criteria

• Provision of signed written and dated informed consent
• BMI between 19 and 27 kg/m2
• Subjects must be willing to use barrier methods of contraception

Exclusion Criteria

• History of any clinical significant disease
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD4017	AZD4017 in ascending doses (start dose 2mg)
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables	The variables will be measure predose and the repeatedly during the following 47 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F)	Blood samples for determination of AZD4017 concentartion will be taken predose and repeatedly during the 47 hours post dose

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan