Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses

Diabetes Mellitus Type 2 Clinical Trial

— MAD  

Official title:

A Randomised, Single-blind, Placebo-controlled, Single Centre, Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841048
• Other study ID #: D2060C00002
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2009
• Last updated: September 29, 2009
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 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 clinically 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 liver enzymes (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

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• AZD4017
ascending multiple doses(start dose 75mg od), oral suspension
• Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Gothenburg

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, laboratory variables		The variables will be measured predose and then repeatedly during the study	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 concentration will be taken predose and repeatedly during the study.	Yes
Secondary	Laboratory screen to evaluate effect on metabolic variables		Blood samples will be taken pre-dose and repeatedly during the study	Yes
Secondary	Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues		Baseline and repeatedly after treatment	Yes