A Phase 1 interventional study of AZD5658 and Placebo in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-02-02.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.
This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus 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.
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Exclusion Criteria:
6 patients in each cohort will receive AZD5658
Drug: AZD5658 · Drug: Placebo
2 patients in each cohort will receive placebo
Drug: AZD5658 · Drug: Placebo
oral suspension, escalating single doses
oral suspension,single doses
To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).
Time frame: AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3
To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.
Time frame: Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose
Pharmacodynamics (plasma glucose and serum insulin)
Time frame: Plasma glucose and serum insulin determined on Day -1 through Day 4
Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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AstraZeneca