Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017

Healthy Clinical Trial

Official title:

A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase 1Study in Healthy Volunteers to Assess the Safety, Tolerability andPharmacokinetics of AZD4017 After Single Ascending Oral Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791752
• Other study ID #: D2060C00001
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2008
• Last updated: June 15, 2009
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to healthy 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of signed written and dated informed consent

• BMI between 19 and 30 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD4017
ascending single doses (start dose 2 mg), oral suspension
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Gotteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratoryvariables		The variables will be measure predose and the repeatedly during the following 47 hours after dosing	Yes
Secondary	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 concenration will be taken predose and repeatedly during the 47 hours post dose	Yes