#131 PK, PD, safety, R - 5, 10, 25, 50, sd 23 Healthy tolerability, 100, 200 mg Phase I (up to 4) food effect, R - capsules (5, 25 mg); tablets 25 mg #132 PK, PD, safety, R- 15, 25, 50 mg md 71 Healthy tolerability bd; 50, 100 mg qd Phase I (10 days R capsules (5, – 25 mg) Placebo #134 Mass-balance R oral solution, sd 6 Healthy – and 25 mg of 100µCI Phase I metabolites 14C-ruxolitinib #138 QTc interval; R 25 mg sd (x2) 48 Healthy – PK (tablets); placebo; Phase moxifloxacin 400 mg; #139 R - IR, SR1, SR2 sd (x3) 9 Healthy – relative) 25 mg (tablets) – Phase 1 IR and SR tablets Table 6: Pharmacokinetics - hepatic and renal impairment. Study Objectives Doses Duration N Subjects #137 Hepatic R 25 mg sd 32 Healthy – impairment (tablet) – HI PK #142 R 25 mg sd 40 Healthy – impairment - (tablet) RI PK 7: Pharmacokinetics interaction studies. – Study Objectives Duration N Subjects #135 Interaction (PK R 50 mg (2x25 sd (x2) 12 Healthy – and PD) mg tablets) – rifampin on ruxolitinib #133 Interaction (PK R 10 mg (2x5 sd (x 2) 31 Healthy – and PD) mg capsules); – ketoconazole,
#131 Phase I PK, PD, safety, tolerability, food effect, R - 5, 10, 25, 50, 100, 200 mg R - capsules (5, 25 mg); tablets 25 mg sd (up to 4) 23 Healthy #132 Phase I PK, PD, safety, tolerability R- 15, 25, 50 mg bd; 50, 100 mg qd R – capsules (5, 25 mg) Placebo md (10 days 71 Healthy #134 Phase I Mass-balance and metabolites R – oral solution, 25 mg of 100µCI 14C-ruxolitinib sd 6 Healthy #138 Phase QTc interval; PK R – 25 mg (tablets); placebo; moxifloxacin 400 mg; sd (x2) 48 Healthy #139 Phase 1 – relative) IR and SR tablets R - IR, SR1, SR2 – 25 mg (tablets) sd (x3) 9 Healthy Table 6: Pharmacokinetics - hepatic and renal impairment. Study Objectives Doses Duration N Subjects #137 Hepatic impairment – PK R – 25 mg (tablet) sd 32 Healthy HI #142 impairment - PK R – 25 mg (tablet) sd 40 Healthy RI 7: Pharmacokinetics – interaction studies. Study Objectives Duration N Subjects #135 Interaction (PK and PD) – rifampin on ruxolitinib R – 50 mg (2x25 mg tablets) sd (x2) 12 Healthy #133 Interaction (PK and PD) – ketoconazole, R – 10 mg (2x5 mg capsules); sd (x 2) 31 Healthy