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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Akros Pharma Inc.

Criteria

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.