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

NCT00841048 | Completed Phase 1

• 1 other identifier: D2060C00002
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus Type 2

Keywords

Safety and tolerability

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables

  The variables will be measured predose and then repeatedly during the study

Secondary Outcomes (3)

• 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.

• Laboratory screen to evaluate effect on metabolic variables

  Blood samples will be taken pre-dose and repeatedly during the study

• Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues

  Baseline and repeatedly after treatment

Study Arms (2)

1

EXPERIMENTAL

AZD4017 in ascending doses (start dose 75mg od)

Drug: AZD4017

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD4017 DRUG

ascending multiple doses(start dose 75mg od), oral suspension

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 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 30 kg/m2
• Subjects must be willing to use barrier methods of contraception

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marianne Hartford, MD PhD

  AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg Sweden

  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: February 10, 2009
• First Posted: February 11, 2009
• Study Start: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 30, 2009

Record last verified: 2009-09

Locations

SE (1)