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

A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study in Healthy Japanese Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD4017 After Single Ascending Oral Doses

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00799747

Enrollment

Registered

2008-12-01

Start date

2008-12-31

Completion date

2009-04-30

Last updated

2009-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

safety, tolerability, pharmacokinetics, AZD4017Japanese

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.

Interventions

DRUGAZD4017

ascending single doses (start dose 2 mg), oral suspension

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026