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

NCT00749788 | Completed Phase 2

• 1 other identifier: AT302-U-06-003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in HDL-C at Week 4

  4 weeks

Secondary Outcomes (2)

• Percent change and change from baseline at week 4 in lipid parameters

  4 weeks

• Evaluate the safety profile of JTT-302 when administered for 4 weeks

  4 weeks

Study Arms (3)

1

EXPERIMENTAL

JTT-302, 200 mg

Drug: JTT-302

2

EXPERIMENTAL

JTT-302, 400 mg

Drug: JTT-302

3

PLACEBO COMPARATOR

Matching placebo tablets

Drug: Placebo

Interventions

JTT-302 DRUG

JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal

1

Placebo DRUG

Matching placebo tablets, oral, 30 minutes after the start of the morning meal

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akros Pharma Inc.: lead

Study Sites (1)

Unknown Facility

Santa Ana, California, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: December 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

US (1)