Hypercholesterolemia Clinical Trial
Official title:
Phase I Randomized Placebo Controlled Double Blind SAD and MAD Study of Oral AHRO-001 to Assess Safety, Tolerability &PK in Volunteers w/Mild/Moderate Hypercholesteremia
Verified date | November 2014 |
Source | AtheroNova Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Russia: Ministry of Health of the Russian Federation |
Study type | Interventional |
Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque burden.
Status | Active, not recruiting |
Enrollment | 110 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Key Inclusion Criteria: - Males OR infertile Females - 18-70 years of age, inclusive - Asymptomatic mild to moderate hypercholesterolemia, (LDL =110-220 mg/dL) - Cohort 5: on no statin or on a stable statin dose not meeting LDL >110 mg% Key Exclusion criteria - Fasting triglycerides <90 or >250 mg/dl (<0.85 mmol/l or >2.8 mmol/l) - Body Mass Index (BMI) <18 or >34 kg/m2 - Diabetes mellitus (FBS > 125 mg% (>6.94 mmol/l) - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >ULN - Serum creatinine >ULN for gender - Hemoglobin <11.5 g/dL - Female volunteers of childbearing potential - History of cancer in past 5 years - Any disease requiring medication - Use of investigational medication in past 3 months - Positive results for illegal drugs, HBsAg, HBsAb, HCV or HIV - Cohort 5:Prescription lipid lowering medications other than a statin in past 4 wks - Cohort 5: History of gastrointestinal tract surgical resection |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | City Hospital #15 | Moscow |
Lead Sponsor | Collaborator |
---|---|
AtheroNova Inc. |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | To assess the safety, tolerability and pharmacokinetics of AHRO-001 when administered first as a single daily dose x 1 day, then by a graduated increase from daily dosing x 1day to twice daily dosing x7 days, and ultimately to thrice daily dosing x7. Next dose can be started as soon as 6 volunteers will finish 2 weeks of administration of the previous dose. All dose increases occur only after drug washout and are only undertaken after medical review of the previous dose as determined by symptoms, vital signs, clinical examination, clinical laboratory results, urinalyses, electrocardiograms and adverse event reporting declares that progression of dosing is safe and appropriate | Participants will be followed through the course of their participation, approximately 8 weeks | Yes |
Secondary | Number of participants with adverse events | To assess the safety, tolerability and pharmacokinetics of AHRO-001 dosed tid for 21 days at best tolerated dose as determined in Cohorts 1-3. | Participants will be followed through the course of their participation, approximately 8 weeks | Yes |
Secondary | Number of participants with adverse effects | To assess the safety, tolerability and pharmacokinetics of AHRO-001 administered orally as a tid regimen for 12 weeks in the presence or absence of a statin, at a dose determined by safety in the first 4 dose cohorts. | Participants will be followed through the course of their participation, approximately 16 weeks | Yes |
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