Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akros Pharma Inc.

Criteria

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