TABLE 4.
Descriptive summary of key plasma pharmacokinetic parameters on Day 56 (steady state) following twice‐daily oral dosing of danuglipron
| Parameter | Danuglipron dose | ||
|---|---|---|---|
| 40 mg BID (N = 10) | 80 mg BID (N = 9) | 120 mg BID (N = 9) | |
| N2, N3 | 7, 6 | 6, 3 | 7, 7 |
| AUC24 (ng·h/ml) | 2424 (45) | 4691 (75) | 6953 (148) |
| AUC24(dn) (ng·h/ml/mg) | 30.29 (45) | 29.35 (75) | 28.94 (148) |
| Cmax (ng/ml) | 136.0 (51) | 245.3 (67) | 415.8 (153) |
| Cmax(dn) (ng/ml/mg) | 3.401 (51) | 3.068 (67) | 3.465 (152) |
| Tmax (h) | 6.00 (2.00‐6.00) | 6.00 (2.00‐8.00) | 6.00 (0.000‐10.1) |
| t1/2 (h) | 6.373 ± 1.7404 | 5.543 ± 0.30827 | 5.300 ± 0.80594 |
Note: data are geometric mean (% CV) for all except arithmetic mean ± standard deviation for t1/2 and median (range) for Tmax. N is the total number of participants in the indicated treatment group. N2 is the number of participants contributing to the summary statistics. N3 is the number of participants contributing to the summary statistics for t1/2. If a participant received a dose that was not assigned based on the randomized titration scheme, the data from that day were not included in summary statistics.
Abbreviations: AUC, area under the plasma concentration‐time curve; AUC24, AUC from time 0 to 24 h; BID, twice daily; Cmax, maximum plasma concentration during the dosing interval τ1 = 0‐10 h; CV, coefficient of variation; dn, dose normalized to a 1‐mg dose; t½, terminal half‐life; Tmax, time to Cmax.