Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
The purpose of this study is to determine the effect of JTT-302 on the increase of High
 Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in
 subjects with low HDL-C levels.
Inclusion Criteria:

 -  Subjects with a Body Mass Index (BMI)≤ 35 kg/m2

 -  Subjects with the following lipid parameters at Visit 1 (screening visit) and Visit 3
 (diet stabilization period):

 -  HDL-C ≤ 40 mg/dL (Men) and ≤ 50 mg/dL (Women)

 -  TG ≤ 500 mg/dL

 -  LDL-C ≤ 190 mg/dL

 -  Subjects who are generally healthy as determined by pre-study medical history,
 physical examination, vital signs and 12-lead ECG

 Exclusion Criteria:

 -  Females who are pregnant or breast-feeding

 -  AST, ALT or total bilirubin ≥ 2.0 x ULN at Visit 1 (screening visit) or Visit 3 (diet
 stabilization period)

 -  Serum thyroid stimulating hormone (TSH) and levothyroxine (T4) outside of the central
 laboratory reference range at the screening visit

 -  Medical history of diabetes mellitus or two fasting serum glucose measurements > 126
 mg/dL at the screening visit

 -  Subjects with hypertension, or two blood pressure measurements ≥ 140 mm Hg systolic or
 ≥ 90 mm Hg diastolic at the screening visit

 -  History of drug or alcohol abuse within 12 months of the screening visit

 -  Use of medications defined in the protocol within six-weeks prior to the screening
 visit and throughout the study

 -  Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol within
 four weeks of the screening visit and throughout the study