Table 2.

Omaveloxolone PK parameters for Friedreich’s ataxia patients

Dose (mg)	N	Body weight (kg)	Dose (mg/kg)	Tmaxa (hours)	Cmax (ng/mL)	AUC(0–24 h) (h×µg/mL)	AUC(0–24 h)/Dose ([h×µg/mL]/[mg/kg])	T1/2z (hours)
2.5b	6	64.4±14.3	0.0403±0.0081	2	2.20±0.94	0.0187±0.0064	0.458±0.126	17.4±7.6
5c	5	66.7±14.6	0.0777±0.0162	2	5.16±3.55	0.0381±0.0157	0.493±0.210	14.7±3.6
10	6	72.8±28.7	0.151±0.042	2	10.3±4.8	0.134±0.053	0.948±0.376	20.6±19.4
20	5	56.5±5.0	0.356±0.033	2	18.1±6.4	0.225±0.043	0.630±0.085	18.3±1.6
40	6	78.3±20.0	0.541±0.144	2	24.9±6.6	0.326±0.627	0.639±0.211	16.8±7.7
80	6	64.6±5.2	1.25±0.10	3	48.0±26.6	0.627±0.250	0.496±0.182	15.0±4.6
160	12	68.1±12.0	2.14±0.38	2	112±52	1.26±0.37	0.551±0.253	21.0±9.0
300	5	86.8±18.5	3.57±0.68	2	162±35	2.08±0.52	0.591±0.139	16.4±5.8

Notes:

^aValues represent mean ± SD except for T_max where median values are shown. PK samples were collected at 0, 1, 2, 4, and 8 hours; for the purposes of calculating PK parameter values it was assumed that the concentration at 24 hours was identical to the concentration at 0 hours (steady state).

^bData for the 2.5-mg dose obtained from Cohort 1 at week 2 prior to intrapatient dose escalation.

^cData for the 5-mg dose obtained from Cohort 1 at week 8 (ie, 6 weeks after intrapatient dose escalation from 2.5 mg).

Abbreviations: AUC, area under the curve; C_max, maximum plasma concentration; PK, pharmacokinetic; T_1/2, terminal half-life; T_max, time to maximum plasma concentration.