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

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: JTT-302; Drug: Placebo

• Registration Number: NCT00749788
• Lead Sponsor: Akros Pharma Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-09
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-31
• Disposition First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Disposition First Posted: 2013-02-04
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	JTT-302	JTT-302, 200 mg
3	Placebo	Matching placebo tablets
2	JTT-302	JTT-302, 400 mg

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in HDL-C at Week 4	4 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change and change from baseline at week 4 in lipid parameters	4 weeks
Evaluate the safety profile of JTT-302 when administered for 4 weeks	4 weeks