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

An Eight Week, Open-label Extension Study Evaluating the Safety of JTT-302 Administered Once Daily in Subjects With Low HDL-C Levels Who Have Completed the Treatment Phase of Study AT302-U-06-003

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00748852

Enrollment

103

Registered

2008-09-09

Start date

2007-01-31

Completion date

2008-03-31

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

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.

Interventions

DRUGJTT-302

JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks	12 weeks

Secondary

Measure	Time frame
Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters	4, 8 or 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026