Table 3.
Uncorrected, pre-dose corrected PK parameters for testosterone in the phase 1 PK study (n=14)
| Uncorrected PK parameters | Corrected PK parameters | |||||
|---|---|---|---|---|---|---|
|
| ||||||
| Asymptomatic | Symptomatic | Symptomatic treated | Asymptomatic | Symptomatic | Symptomatic treated | |
| Mean TNSS | ||||||
| TNSS | 0 (0) | 7.20 (1.94) | 6.54 (1.92) | 0 (0) | 7.20 (1.94) | 6.54 (1.92) |
| Mean testosterone PK parameters | ||||||
| Pre-dose g/dL | 534 (106) | 423(141) | 402 (109) | — | — | — |
| Tmax, min | 53.1(29) | 47.8 (32) | 49.5 (26) | — | — | — |
| Cmin, nd/dL | 468 (94) | 344 (114) | 345 (93) | — | — | — |
| Cmax, nd/dL | 1063 (223) | 910 (242) | 872 (268) | 527 (176) | 487 (151) | 470 (194) |
| AUC, ng/dL h | 16747 (3894) | 13217 (3589) | 12778 (3380) | 3841 (2713) | 3041 (1967) | 3139 (1480) |
Negative value (−50 to −77 ng/dL) at t=13.75h in PK profile for all three conditions. AUC: area under the curve; Cmax: maximum observed concentration; Cmin: minimum observed concentration; PK: pharmacokinetics; TNSS: Total Nasal Symptom Scores.