Table 2.
Change in Safety Parameters From D 1 to D 28 by Treatment Group (Median and 25th and 75th Percentiles)
| Parameter | Baseline Value | Placebo | C100 | C200 | P200 | P400 | C400 | P Value | R 2 |
|---|---|---|---|---|---|---|---|---|---|
| No. of subjects | 27 | 16 | 15 | 18 | 9 | 15 | |||
| Hematocrit, % | 41.7 (40, 43) | −1 (−1.8, 0) | 1.1 (0, 3) | 0 (−0.5, 2) | 2 (1, 2.3) | 0.4 (−2, 1) | 2 (1, 3) | 0.007a | 0.56 |
| ALT, IU/L | 17 (13, 24) | −1 (−4, 2) | −4 (−5, 4) | −1 (−3, 4) | 1 (−12, 3) | 5 (−11, 9) | 6 (3, 7) | 0.15 | 0.13 |
| AST (IU/L) | 20 (16, 25) | 0 (−5, 4) | 0 (−1, 2) | 1 (−3, 2) | 0 (0, 1) | 1 (−3, 10) | 5 (0, 7) | 0.50 | 0.03 |
| PSA, ng/mL | 0.6 (0.41, 0.86) | −0.07 (−0.1, 0.02) | 0.08 (0, 0.1) | 0 (−0.08, 0.05) | 0.03 (−0.05, 0.19) | 0.05 (0, 0.2) | 0.03 (0, 0.1) | 0.06 | 0.65 |
| HDL-C, mg/dL | 47.5 (40, 55) | −0.5 (−4, 3) | −6 (−11, −4) | −13 (−19, −8) | −10 (−12, −6) | −15 (−23, −10) | −11 (−15, −7) | <0.001a | 0.62 |
| Weight, kg | 82.7 (74.5, 91.2) | 0.3 (−0.7, 1.2) | 1.5 (0.6, 2.2) | 1.7 (1.1, 3) | 1.9 (1.1, 3.2) | 3.8 (1.7, 4.9) | 2.9 (1.2, 3.6) | <0.001a | 0.99 |
| SBP, mm Hg | 121 (113, 128) | −1.5 (−10, 9) | 0 (−7, 13) | 2 (−7, 8) | 2 (−3, 8) | 1 (−13, 1) | 8 (−8, 15) | 0.82 | 0.26 |
| DBP, mm Hg | 67 (62, 74) | 0 (−5, 4) | −2 (−7, 8) | 3 (−3, 6) | 3 (−3, 4) | 2 (−12, 10) | 3 (−3, 7) | 0.63 | 0.28 |
| Pulse, bpm | 64 (56, 74) | 2.5 (−6, 8) | −3 (−6, 1) | 1.2 (−2, 7) | −1 (−3,4) | 5 (−1,16) | 3 (−1,14) | 0.04 | 0.38 |
| QTc,b msec | 403 (388, 412) | 406 (393, 422) | 386 (380, 408) | 394 (385, 404) | 384 (372, 408) | 386 (371, 408) | 387 (379, 402) | <0.001a | 0.40 |
| PHQ-9 total score | 0 (0, 2) | 1 (0, 3) | 0 (0, 3) | 1 (0, 3) | 0 (0, 1) | 2 (−3, 2) | 1 (−1, 3) | 0.99 | 0.19 |
| PDQ q1 | 4.4 (3.4, 5) | 0.05 (−0.4, 0.9) | −0.1 (−0.4, 0.4) | −0.85 (−1.9, 0.3) | 0.1 (−0.4, 0.6) | 0.3 (−1.1, 1) | −1.3 (−1.6, −0.5) | 0.009a | 0.57 |
| PDQ q4 | 2.4 (1.9, 3.5) | −0.4 (−1.1, 0.4) | −0.15 (−1.2, 1.2) | −0.95 (−1.1, −0.4) | −0.5 (−1.2, 0.3) | −0.3 (−1.1, 0.2) | −0.3 (−1.3, 0.1) | 0.97 | 0.46 |
| PDQ q6 | 5.6 (5.1, 6.7) | 0 (−0.2, 0.3) | 0 (−0.4, 0.3) | −0.65 (−1.9, −0.3) | 0 (−0.8, 0) | 1 (0.2, 1.8) | 0 (−3.7, 0) | 0.93 | 0.48 |
Baseline value is median and 25th and 75th percentile data across all groups on d 1. Note: Data shown is all-treated population. PDQ q1 assessed sexual desire, q4 assessed sexual activity, and q6 assessed erectile function satisfaction.
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; DBP, diastolic blood pressure; SBP, systolic blood pressure.
a
P < 0.01 for dose effect on mixed-model analysis. R2 value is from mixed-model analysis.
b
All parameters are measured as change from d 1 to d 28 (difference) except QTc, which is the absolute value on d 28.