Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatment ahro-001
Phase phase 1
Sponsor AtheroNova Inc.
Start date June 2013
End date June 2015
Trial size 110 participants
Trial identifier NCT01931241, AHRO-001-12-101

Summary

Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque burden.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Cohort 1 receives SDD 500 mg AHRO-001; one week later receives MDD of 500 mg bid 7 days, then 500 mg tid 7 days
ahro-001 HDCA
Cohort 1: 500 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 2: 750 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 3: 1000 mg/dose, given as a single dose then as bid x7days and tid x7days Cohort 4: 21 days dosing given at best tolerated dose determined by cohorts 1-3 Cohort 5: 12 wks dosing given at best tolerated dose determined by cohorts 1-4
(Experimental)
Cohort 2 receives SD of 750 AHRO-001, then 7 days of 750 mg BID AHRO-001, then 7 days of 750 mg TID AHRO-001.
ahro-001 HDCA
Cohort 1: 500 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 2: 750 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 3: 1000 mg/dose, given as a single dose then as bid x7days and tid x7days Cohort 4: 21 days dosing given at best tolerated dose determined by cohorts 1-3 Cohort 5: 12 wks dosing given at best tolerated dose determined by cohorts 1-4
(Experimental)
Cohort 3 identical design as Cohorts 1 and 2, but SD is 1000 mg AHRO-001.
ahro-001 HDCA
Cohort 1: 500 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 2: 750 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 3: 1000 mg/dose, given as a single dose then as bid x7days and tid x7days Cohort 4: 21 days dosing given at best tolerated dose determined by cohorts 1-3 Cohort 5: 12 wks dosing given at best tolerated dose determined by cohorts 1-4
(Experimental)
Cohort 4 receives 21 days tid administration of AHRO-001 using the best tolerated dose as determined by cohorts 1, 2 & 3
ahro-001 HDCA
Cohort 1: 500 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 2: 750 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 3: 1000 mg/dose, given as a single dose then as bid x7days and tid x7days Cohort 4: 21 days dosing given at best tolerated dose determined by cohorts 1-3 Cohort 5: 12 wks dosing given at best tolerated dose determined by cohorts 1-4
(Experimental)
Cohort 5 receives 12 weeks tid administration of AHRO-001 using the best tolerated dose as determined by the first 4 cohorts.
ahro-001 HDCA
Cohort 1: 500 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 2: 750 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 3: 1000 mg/dose, given as a single dose then as bid x7days and tid x7days Cohort 4: 21 days dosing given at best tolerated dose determined by cohorts 1-3 Cohort 5: 12 wks dosing given at best tolerated dose determined by cohorts 1-4

Primary Outcomes

Measure
Number of participants with adverse events
time frame: Participants will be followed through the course of their participation, approximately 8 weeks

Secondary Outcomes

Measure
Number of participants with adverse events
time frame: Participants will be followed through the course of their participation, approximately 8 weeks
Number of participants with adverse effects
time frame: Participants will be followed through the course of their participation, approximately 16 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
Description 4 sequential dosing cohorts, each cohort beginning with single dose (SDD), single day exposure, followed by one week of multiple daily dosing (MDD) with bid exposure, a 4 day drug honeymoon, then one week of MDD utilizing tid exposure. Each subsequent cohort utilizes the same SDD/MDD design, starting with SDD higher than prior SDD but a SDD significantly lower than prior tid MDD cohort just completed, the overall goal being to provide gradually increasing dose exposure contingent on satisfactory safety and tolerability of lower doses in the previous groups. Cohort 4 (MDD) utilizes best dose determined by Cohorts 1, 2 & 3 for 21 days. Estimated Duration of Subject Participation: 8-9 weeks Under Protocol Amendment Version 5.0, an additional cohort, Cohort 5, will concomitantly enroll 48 volunteers randomized to receive either AHRO-001 or placebo. Volunteers included in the study may be either currently receiving or not receiving a statin treatment. The 48 volunteers in Cohort 5 will thus be allocated to 3 treatment groups with 16 volunteers enrolled per group: Group A: AHRO-001 alone Group B: Statin + AHRO-001 Group C: Placebo SUBJECT POPULATION: Healthy volunteers, both males & infertile females, with asymptomatic mild to moderate hypercholesterolemia
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by AtheroNova Inc..