Table 3.
Population Pharmacokinetic/Pharmacodynamic Parameters for the Final Model of the Effect of Tafenoquine or Moxifloxacin Plasma Concentrations on the Baseline Adjusted QTcF Interval Corrected for Placebo and Evaluation of Parameter Stability Using Bootstrap Analysis
| Parameter | Model | Bootstrap analysis | ||
|---|---|---|---|---|
| Mean | %CV | Mean | 95% CI | |
| Fixed effects | ||||
| Baseline male white+ (ms) | 399 | 0.3 | 399 | 397, 401 |
| Baseline female white+ (ms) | 410 | 17.8 | 409 | 404, 415 |
| Baseline male black race (ms) | 391 | 22.0 | 391 | 388, 396 |
| Baseline female black race (ms) | 401 | 22.0 | 401 | 398, 406 |
| Amplitude 8 h (ms) | 4.2 | 3.5 | 4.2 | 3.9, 4.4 |
| tmax 8 h (h) | –10.1 | 0.4 | –10.1 | –10.2, –10.1 |
| Amplitude 24 h (ms) | 4.0 | 4.1 | 4.0 | 3.7, 4.3 |
| tmax 24 h (h) | –4.5 | 3.2 | –4.4 | –4.2, –4.7 |
| Tafenoquine slope (ms/μg mL–1) | 0.5 | 175 | 0.5 | –1.0, 2.3 |
| Moxifloxacin slope (ms/μg mL–1) | 3.1 | 17.0 | 3.1 | 2.3, 4.0 |
| Inter-individual variability | ||||
| %CV (baseline) | 13.9 | 8.0 | 13.8 | 12.9, 14.7 |
| %CV (amplitude 24 h) | 1.6 | 26.0 | 1.6 | 1.2, 1.9 |
| %CV (tmax 24 h) | 1.2 | 25.3 | 1.2 | 1.0, 1.5 |
| %CV (amplitude 8 h) | 0.9 | 53.5 | 0.9 | 0.3, 1.3 |
| %CV (tmax 8 h) | 0.4 | 24.4 | 1.0 | 0.3, 0.5 |
| %CV (moxifloxacin slope) | 3.0 | 30.2 | 2.9 | 2.2, 3.7 |
| Random residual variability (ms) | 5.7 | 2.8 | 5.7 | 5.6, 5.8 |
CI, confidence interval; CV, coefficient of variance; tmax, time of maximum plasma concentration; white+, white plus all other ethnicities except black.