A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels

NCT01388816 | Completed Phase 2 Results

• 1 other identifier: DRL-17822/CD/004
• Study Type: interventional
• Target: 176
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.

Conditions

Type II Hyperlipidemia

Keywords

Randomized; Double-Blind; Placebo Controlled; Parallel Arm; Type II Hyperlipidemia; Cholesteryl Ester Transferase Protein Inhibitor; CETP Inhibitor

Outcome Measures

Primary Outcomes (1)

• Percent Change in HDL-C From Baseline

  Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia

  28 days

Secondary Outcomes (5)

• Safety and Tolerability of DRL-17822

  28 days

• Changes in Vital Signs Including Blood Pressure

  28 days

• To Evaluate Trough Levels of DRL-17822 in Plasma

  28 days

• Changes in CETP Inhibition in Plasma

  28 days

• Changes in Other Lipids and Apolipoproteins

  28 days

Study Arms (4)

Placebo capsule

PLACEBO COMPARATOR

Drug: DRL-17822 or placebo

DRL-17822 50 mg

EXPERIMENTAL

Drug: DRL-17822 or placebo

DRL-17822 150 mg

EXPERIMENTAL

Drug: DRL-17822 or placebo

DRL-17822 300 mg

EXPERIMENTAL

Drug: DRL-17822 or placebo

Interventions

DRL-17822 or placebo DRUG

DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast

DRL-17822 150 mg; DRL-17822 300 mg; DRL-17822 50 mg; Placebo capsule

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Type II hyperlipidemia having lipid values of HDL-C: males ≤ 44 mg/dL (≤1.13 mmol/L), females ≤ 54 mg/dL (≤1.39 mmol/L); LDL-C: ≥ 130 mg/dL (≥3.33 mmol/L);
• Male or female, 18 to 70 years of age, inclusive. Female patients must be postmenopausal or surgically sterile. Men, unless surgically sterile must practice birth control from screening until the end of the study;
• Ability and willingness to give written informed consent;
• No clinically significant abnormal findings on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory profiles of both blood and urine.

You may not qualify if:

• Patients with significant cardiac disease such as myocardial infarction, heart failure, coronary or peripheral artery angioplasty, bypass graft surgery, severe or unstable angina pectoris, cardiac arrhythmias, hypertension or any other disease which requires treatment;
• Uncontrolled diabetes (HbA1c \> 8.0%);
• History of symptomatic cerebrovascular disease such as symptomatic carotid artery disease, cerebrovascular hemorrhage, transient ischemic attack or carotid endarterectomy or any disease which requires treatment;
• History of clinically significant hematologic, renal, hepatic, neurologic, endocrine, oncologic, pulmonary, immunologic or psychiatric disorders;
• Any current or recent (within 4 weeks of run-in) concomitant therapy (apart from paracetamol/acetaminophen and non-steroidal anti-inflammatory drugs \[NSAIDs\]). Patients on previous concomitant treatment may enter the study if the treatment has been discontinued, when appropriate and if ethically justified, at least four weeks prior to run-in;
• Body mass index (BMI)\> 35 kg/m(2);
• Positive for hepatitis B, C or HIV or known history or concurrent tuberculosis;
• Positive drug screen result (i.e., cocaine, opiates, amphetamine, cannabis, barbiturates, benzodiazepines and/or metadone);
• Pregnant, breast feeding or women of child-bearing potential;
• Regular use of non-drug therapies such as garlic supplements and St. John's Wort;
• Presence or history of alcoholism or drug abuse;
• Use of more than 21 units of alcohol per week for males or more than 14 units per week for females;
• Smoking within 3 months prior to screening;
• Relevant drug hypersensitivity or allergy or any serious adverse event reaction to lipid regulating agents;
• Administration of study drug in another drug study within 90 days prior to enrollment or participation in another drug trial from screening to last follow-up of this study; Any surgical or medical condition which makes the patient unsuitable to participate in the opinion of the Investigator.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead
• PharmaNet: collaborator

Study Sites (12)

Unknown Facility

Genova, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Modena, Italy

Location

Unknown Facility

Palermo, Italy

Location

Unknown Facility

Perugia, Italy

Location

Unknown Facility

Gdynia, Poland

Location

Unknown Facility

Gniewkowo, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Chernivtsi, Ukraine

Location

Unknown Facility

Kharkiv, Ukraine

Location

Unknown Facility

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

DRL-17822

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Kent Allenby, MD
• Organization: Proprietary Products, Dr. Reddy's Laboratories, Inc.

kallenby@drreddys.com

609-375-9855

Study Officials

• Kent Allenby, MD

  Dr. Reddy's Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 22, 2014
• Results First Posted: April 22, 2014

Record last verified: 2014-03

Locations

IT (5); PL (4); UA (3)