A Phase 1 interventional study of AZD4017 and Placebo in Diabetes Mellitus Type 2, sponsored by AstraZeneca. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-30.
Sponsored by AstraZeneca · Phase 1 and Interventional
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 107 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AZD4017 in ascending doses (start dose 75mg od)
Drug: AZD4017
Placebo
Drug: Placebo
ascending multiple doses(start dose 75mg od), oral suspension
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
Time frame: The variables will be measured predose and then repeatedly during the study
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 concentration will be taken predose and repeatedly during the study.
Laboratory screen to evaluate effect on metabolic variables
Time frame: Blood samples will be taken pre-dose and repeatedly during the study
Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues
Time frame: Baseline and repeatedly after treatment
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca