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
Overview
- Phase
- Phase 1
- Intervention
- AZD4017
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratoryvariables
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
1
AZD4017 in ascending doses (start dose 2mg)
Intervention: AZD4017
2
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- 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)