* Open-label, randomized, single-dose study with 2 Single dose for Group 1 or 14mg for Group 2 20M/10F parallel groups and a 2-treatment by 2- sequence 1 centre Cholestyramine for 5d 1: 39.6 ± crossover 12.5 (23-60)y France Group 2: 36.8 ± Jan May 2010 14.3 (20 – —58)y Grp 1:16 Grp 2: 14 Intrinsic Factor PK Reports POP6507 Assess PK of a single teriflunomide 14mg dose in Teriflunomide 14mg tablets 25/24 patients with mild and moderate hepatic * Single dose of 14mg under fasted conditions on Dl 19M/6F impairment (HI) and in matched subjects with 1 centre Activated charcoal for 2 d (054 through D55) to 47.0 ± 11.9 (25 normal liver function assist washout - 62)y Mild HI: Russia single-dose, parallel design study in 3 9; Moderate HI: groups of subjects Dec 2007 Jun 8; Healthy: 8 – 2008 POP11432 Assess effect of severe renal impairment on PK of a Teriflunomide 14mg tablets 16/16 single 14mg dose teriflunomide. * Single dose of 14mg under fasted conditions on Dl 12M/4F Open-label, single-dose study 1 centre Cholestyramine for 2 d 59.5 ± 5.6 (41 - 75)y Germany 8 severe renal impairment;
* 1 centre France Jan – May 2010 Open-label, randomized, single-dose study with 2 parallel groups and a 2-treatment by 2- sequence crossover Single dose for Group 1 or 14mg for Group 2 Cholestyramine for 5d 20M/10F 1: 39.6 ± 12.5 (23-60)y Group 2: 36.8 ± 14.3 (20 —58)y Grp 1:16 Grp 2: 14 Intrinsic Factor PK Reports POP6507 * 1 centre Russia Dec 2007 – Jun 2008 Assess PK of a single teriflunomide 14mg dose in patients with mild and moderate hepatic impairment (HI) and in matched subjects with normal liver function single-dose, parallel design study in 3 groups of subjects Teriflunomide 14mg tablets Single dose of 14mg under fasted conditions on Dl Activated charcoal for 2 d (054 through D55) to assist washout 25/24 19M/6F 47.0 ± 11.9 (25 - 62)y Mild HI: 9; Moderate HI: 8; Healthy: 8 POP11432 * 1 centre Germany Assess effect of severe renal impairment on PK of a single 14mg dose teriflunomide. Open-label, single-dose study Teriflunomide 14mg tablets Single dose of 14mg under fasted conditions on Dl Cholestyramine for 2 d 16/16 12M/4F 59.5 ± 5.6 (41 - 75)y 8 severe renal impairment;
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