Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Masking: Single (Participant)

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • AZD4017 in ascending doses (start dose 2mg)
  • Placebo Comparator: 2
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratoryvariables
    • Time Frame: The variables will be measure predose and the repeatedly during the following 47 hours after dosing

Secondary Measures

  • 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)
    • Time Frame: Blood samples for determination of AZD4017 concenration will be taken predose and repeatedly during the 47 hours post dose

Participating in This Clinical Trial

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).

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden
  • Overall Official(s)
    • Marianne Hartford, MD PhD, Principal Investigator, Sahlgrenska University Sweden

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