Table 3.
Effect of DA-8031 on the QTcB and QTcF intervals after a single oral administration of placebo or DA-8031, 5–120 mg
| Dose of DA-8031 | QTcB interval (ms)
|
QTcF interval (ms)
|
||||||
|---|---|---|---|---|---|---|---|---|
| QTcmaxa | P-valueb | ΔQTcmaxa | P-valueb | QTcmaxa | P-valueb | ΔQTcmaxa | P-valueb | |
| Placebo | 409±18 (0/14) |
9±14 | – | 411±17 (0/14) |
8±9 | – | ||
| 5 mg | 403±12 (0/8) |
0.953 | 6±11 | 1.000 | 408±14 (0/8) |
1.000 | 5±11 | 1.000 |
| 10 mg | 410±15 (0/8) |
0.997 | 10±16 | 1.000 | 415±13 (0/8) |
0.997 | 8±14 | 1.000 |
| 20 mg | 419±8 (0/8) |
0.712 | 9±8 | 1.000 | 418±12 (0/8) |
0.921 | 12±8 | 1.000 |
| 40 mg | 415±17 (0/8) |
0.975 | 17±3 | 0.768 | 419±18 (0/8) |
0.857 | 21±4 | 0.009 |
| 60 mg | 429±23 (1/8) |
0.064 | 27±13 | 0.167 | 430±29 (2/8) |
0.111 | 29±9 | 0.005 |
| 80 mg | 421±25 (1/8) |
0.521 | 25±6 | 0.037 | 426±25 (2/8) |
0.320 | 23±9 | 0.071 |
| 120 mg | 457±13 (6/8) |
<0.001 | 48±9 | <0.001 | 454±16 (5/8) |
<0.001 | 46±14 | 0.001 |
Notes:
a
Values are expressed as mean ± standard deviation and as (subjects who experienced >450 ms QTc interval/total subjects in the dose group).
b
P-value for differences of QTcmax and maximum changes in QTc from baseline between each DA-8031 dose groups and placebo.
Abbreviations: QTc, heart rate-corrected QT intervals; QTcB, heart rate-corrected QT intervals using Bazett’s formula; QTcF, heart rate-corrected QT intervals using Fridericia’s formula.