Table 1.
Parameter | Cohort 1: Gln-1062 5.5 mg |
Cohort 2: Gln-1062 11 mg |
Cohort 3: Gln-1062 22 mg |
Cohort 4: Gln-1062 33 mg |
Cohort 5: Gln-1062 44 mg |
|||||
---|---|---|---|---|---|---|---|---|---|---|
Mem | Gal | Mem | Gal | Mem | Gal | Mem | Gal | Mem | Gal | |
Cmax (ng/mL) | 15.2 (6.51–29.9) | 17.6 (13.0–21.6) | 19.4 (7.40–5.42) | 27.7 (19.0–41.2) | 26.5 (12.3–39.2) | 46.5 (29.2–67.2) | 58.5 (16.4–103) | 76.1 (49.2–121) | 43.2 (16.9–97.3) | 74.7 (42.7–114) |
Tmax (h) | 0.29 (0.25–0.50) | 2.27 (1.00–3.53) | 0.48 (0.25–1.00) | 4.35 (1.53–10.0) | 0.60 (0.50–1.00) | 3.28 (1.57–4.02) | 0.59 (0.25–1.53) | 4.58 (2.00–9.89) | 0.71 (0.25–1.67) | 4.66 (2.82–8.00) |
AUC 0-inf (ng*h/mL) | 20.0 (11.6–35.8) | 268 (166–445) | 32.9 (16.2–71.8) | 367 (273–489) | 69.1 (40.8–95.4) | 799 (629–954) | 125 (49.3–221) | 1190 (926–1800) | 112 (69.6–177) | 1530 (826–3270) |
T1/2 (h) | 1.07 (0.68–1.51) | 9.85 (6.28–19.9) | 1.37 (0.83–1.93) | 7.94 (4.92–10.4) | 2.64 (1.37–4.64) | 8.71 (6.85–12.1) | 2.34 (1.39–2.87) | 9.24 (6.67–11.2) | 2.80 (1.79–3.97) | 11.1 (4.27–18.1) |
Abbreviations: AUC, area under the curve; T1/2, half-life; Cmax, maximum concentration; Tmax, time of maximum concentration.
NOTE. Mean, range in parentheses.