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Table 2 Overall demographic and baseline characteristics

From: Assessment of Pharmacokinetic Interactions Between Obeticholic Acid and Caffeine, Midazolam, Warfarin, Dextromethorphan, Omeprazole, Rosuvastatin, and Digoxin in Phase 1 Studies in Healthy Subjects

  Study I
N = 48
Study II
N = 44
Study III
N = 48
Study IV
N = 48
Study V
N = 48
Age, years 35.0 (9.5) 35.0 (9.4) 32.9 (8.5) 37.9 (9.5) 35.4 (8.7)
Sex, n (%)
 Female 22 (46%) 15 (34%) 17 (35%) 12 (25%) 14 (29%)
 Male 26 (54%) 29 (66%) 31 (65%) 36 (75%) 34 (71%)
Race, n (%)
 White 28 (58%) 27 (61%) 24 (50%) 32 (67%) 23 (48%)
 Other 20 (42%) 17 (39%) 24 (50%) 16 (33%) 25 (52%)
Ethnicity, n (%)
 Not Hispanic or Latino 37 (77%) 29 (66%) 39 (81%) 28 (58%) 35 (73%)
Height, cm 170.1 (8.4) 170.6 (8.0) 170.8 (8.0) 171.5 (10.8) 170.7 (8.5)
Weight, kg 75.2 (12.3) 76.3 (10.6) 76.2 (11.8) 78.1 (12.7) 75.0 (11.8)
BMI, kg/m2 25.9 (2.9) 26.1 (2.3) 26.0 (2.9) 26.4 (2.4) 25.7 (2.9)
Discontinuationsa
 Overall, n (%) 3 (6%) 1 (2%) 1 (2%) 0 (0%) 0 (0%)
  10 mg OCA, n (%) 0 (0%) 0 (0%) 1 (4%) 0 (0%) 0 (0%)
  25 mg OCA, n (%) 3 (13%) 1 (4%) 0 (0%) 0 (0%) 0 (0%)
  1. Data are presented as n (percentage of subjects) or mean (SD), as appropriate
  2. BMI body mass index
  3. aDiscontinuations are given as n (percentage of subjects) where n represents the number of subjects in each treatment group