Safety Study of JTT-302 in Subjects With Low HDL-C Levels
- Registration Number
- NCT00748852
- Lead Sponsor
- Akros Pharma Inc.
- Brief Summary
The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or 12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid parameters and CETP activity and mass.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
- Subjects must have successfully completed the 4-week treatment period of study AT302-U-06-003
Exclusion Criteria
- Females who are pregnant or lactating, and females of child bearing potential who are not using an effective method of contraception
- Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol
- Subjects who cannot follow the prescription and OTC medication restrictions defined in the protocol
- Flu-shots not permitted during the study, including the follow-up period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 JTT-302 JTT-302, 400 mg
- Primary Outcome Measures
Name Time Method Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks 12 weeks
- Secondary Outcome Measures
Name Time Method Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters 4, 8 or 12 weeks