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

NCT00799747 | Completed Phase 1

• 1 other identifier: D2060C00007
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

safety; tolerability; pharmacokinetics; AZD4017Japanese

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

AZD4017 in ascending doses (start dose 2mg)

Drug: AZD4017

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD4017 DRUG

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

1

Placebo DRUG

placebo

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Japan

Location

MeSH Terms

Interventions

2-(1-(5-(cyclohexylcarbamoyl)-6-propylsulfanylpyridin-2-yl)-3-piperidyl)acetic acid

Study Officials

• Shunji Matsuki

  Kyusyu Clinical Phramacology Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: July 2, 2009

Record last verified: 2009-06

Locations

JP (1)