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

Dyslipidemia Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-302 Administered Daily for Four Weeks in Subjects With Low HDL-C Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749788
• Other study ID #: AT302-U-06-003
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2008
• Last updated: January 31, 2013
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: January 2013
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• JTT-302
JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal
• JTT-302
JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal
• Placebo
Matching placebo tablets, oral, 30 minutes after the start of the morning meal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in HDL-C at Week 4		4 weeks	No
Secondary	Percent change and change from baseline at week 4 in lipid parameters		4 weeks	No
Secondary	Evaluate the safety profile of JTT-302 when administered for 4 weeks		4 weeks	Yes