Phase 1
Completed N=94
A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects
Healthy Subjects
Source: ClinicalTrials.gov NCT01297062 ↗
Enrolled (actual)
94
Serious AEs
0.4%
Results posted
May 2012
Primary outcomePrimary: Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL) — -2.25; -0.89 msec
Summary
Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL) |
-2.25; -0.89 | — |
| PRIMARY Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL) |
-2.58; -0.56 | — |
| PRIMARY Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL) |
-3.54; -2.41 | — |
| SECONDARY Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2 |
1.91; -3.56 | — |
| SECONDARY Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2 |
9.75; -0.81 | — |
| SECONDARY Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2 |
12.47; 1.56 | — |
| SECONDARY Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo |
0; 0 | — |
| SECONDARY Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo |
0; 0 | — |
| SECONDARY Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3 |
252.74; 399.14; 626.65 | 0.5962 |
Eligibility Criteria
Inclusion Criteria
- Is overtly healthy, as determined by medical history and physical examination
- Has body mass index (BMI) between 25 and 35 kg/m2
- Has fasting serum glucose 450 ms.
- Family history of sudden death
- Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months
Data sourced from ClinicalTrials.gov (NCT01297062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.