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A Study of Atorvo+™ in Healthy Adult Participants
A Phase 1 study will assess the safety, tolerability, and pharmacokinetics of Atorvo+™ in healthy adult participants.
Study details:
This study will be testing an approved dose of atorvastatin (40 mg) and doses of CBD in the approved range (100 mg and 200 mg, approximately 1. 7 mg/kg/day and 3. 3 mg/kg/day for a 60 kg patient, respectively) in the study.
A total of 24 participants are planned to be enrolled into 3 study arms. Eight (8) participants are planned to be randomized in each of Arms 1, 2, and 3. Each arm will consist of a 28-days Screening period, a 28-day treatment period, and a 14-day follow-up period.
Investigational products (IPs) refer to all study treatments and will be administered at the following planned dose levels:. * Arm 1: Atorvastatin (generic formulation) oral tablet 40 mg once daily for 28 days. * Arm 2: Atorvo+™ Low (40 mg Atorvastatin and 100 mg CBD) once daily for 28 days.
* Arm 3: Atorvo+™ High (40 mg Atorvastatin and 200 mg CBD) once daily for 28 days.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 40 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-11-18
Primary completion: 2025-03-18
Study completion finish: 2025-05-03
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06615284
Intervention or treatment
DRUG: Atorvo+™ (Arm1)
DRUG: Atorvo+™ +CBD (Arm 2)
DRUG: Atorvo+™ +CBD (Arm 3)
Conditions
- • Coronary Heart Disease
- • Dyslipidemias
Find a site
Closest Location:
Nucleus Network
Research sites nearby
Select from list below to view details:
Nucleus Network
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm 1
| DRUG: Atorvo+™ (Arm1)
|
EXPERIMENTAL: Arm 2
| DRUG: Atorvo+™ +CBD (Arm 2)
|
EXPERIMENTAL: Arm 3
| DRUG: Atorvo+™ +CBD (Arm 3)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence, severity, and relationship of adverse events (AEs) | Not Specified | Baseline to End of study (Day 42) from first IP dose |
Incidence of serious adverse events (SAEs) | Not Specified | Baseline to End of study (Day 42) from first IP dose |
Incidence of adverse events of special interest (AESIs) | This includes clinically significant abnormal values in liver function tests (LFTs) (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin), myopathy, myositis, myalgia, and type 2 diabetes | Baseline to End of study (Day 42) from first IP dose |
Number of participants with changes in laboratory parameters | hematology, biochemistry, coagulation, and urinalysis), physical examination, vital signs (blood pressure \[BP\], heart rate \[HR\], respiratory rate \[RR\], and body temperature), electrocardiogram (ECG) parameters. | Baseline to End of study (Day 42) from first IP dose |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Changes in Columbia-Suicide Severity Rating Scale (C-SSRS score) | Not Specified | Baseline to End of study (Day 42) from first IP dose |
PK Parameters- Maximum Plasma concentration (Cmax) | Not Specified | Baseline to End of study (Day 42) from first IP dose |
PK Parameters- Time for maximum concentration (Tmax) | Not Specified | Baseline to End of study (Day 42) from first IP dose |
PK Parameters- Area under Curve | Area under curve to the last measurable concentration (AUC0-t), Area under the curve of concentration versus time from zero to infinity (AUC0-∞) and %AUC extra will be assessed. | Baseline to End of study (Day 42) from first IP dose |
PK parameters-Elimination rate constant (Kel) | Not Specified | Baseline to End of study (Day 42) from first IP dose |
PK parameters- Half-life (t½) | Not Specified | Baseline to End of study (Day 42) from first IP dose |
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin. | This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Basal respiration | Baseline to End of study (Day 42) from first IP dose |
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin. | This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- ATP production. | Baseline to End of study (Day 42) from first IP dose |
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin. | This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Proton leak | Baseline to End of study (Day 42) from first IP dose |
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin. | This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Maximal respiration. | Baseline to End of study (Day 42) from first IP dose |
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin. | This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Reserve capacity. | Baseline to End of study (Day 42) from first IP dose |
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin. | This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed-Non-mitochondrial respiration. | Baseline to End of study (Day 42) from first IP dose |
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