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

Akros Pharma Inc.103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Dyslipidemia

Interventions

JTT-302DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Santa Ana, California, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 4, 8 or 12 weeks

Data from ClinicalTrials.gov

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