A Study of Atorvo+™ in Healthy Adult Participants

NCT06615284 | Completed Phase 1 DMC

• 1 other identifier: IB.ATO-875
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1 study will assess the safety, tolerability, and pharmacokinetics of Atorvo+™ in healthy adult participants. .

Conditions

Coronary Heart Disease; Dyslipidemias

Keywords

Atorvastatin; Cannabidiol; CBD; CHD; LDL-C

Outcome Measures

Primary Outcomes (4)

• Incidence, severity, and relationship of adverse events (AEs)

  Baseline to End of study (Day 42) from first IP dose

• Incidence of serious adverse events (SAEs)

  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 Outcomes (12)

• Changes in Columbia-Suicide Severity Rating Scale (C-SSRS score)

  Baseline to End of study (Day 42) from first IP dose

• PK Parameters- Maximum Plasma concentration (Cmax)

  Baseline to End of study (Day 42) from first IP dose

• PK Parameters- Time for maximum concentration (Tmax)

  Baseline to End of study (Day 42) from first IP dose

• PK Parameters- Area under Curve

  Baseline to End of study (Day 42) from first IP dose

• PK parameters-Elimination rate constant (Kel)

  Baseline to End of study (Day 42) from first IP dose

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug- Atorvastatin 40mg Dosage form- Oral tablet Frequency and duration- once daily for 28 days

Drug: Atorvo+™ (Arm1)

Arm 2

EXPERIMENTAL

Drug- Atorvo+™ Low (40 mg Atorvastatin and 100 mg CBD) Dosage form- Oral tablet Frequency and duration- once daily for 28 days

Drug: Atorvo+™ +CBD (Arm 2)

Arm 3

EXPERIMENTAL

Drug- Atorvo+™ High (40 mg Atorvastatin and 200 mg CBD) Dosage form- Oral tablet Frequency and duration- once daily for 28 days

Drug: Atorvo+™ +CBD (Arm 3)

Interventions

Atorvo+™ (Arm1) DRUG

Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).

Arm 1

Atorvo+™ +CBD (Arm 2) DRUG

Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).

Arm 2

Atorvo+™ +CBD (Arm 3) DRUG

Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).

Arm 3

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
• Male or female aged between 40 and 75 years (inclusive at the time of consent).
• Nonsmoker (not used any tobacco products within 2 months prior to Screening). Participants who smoke ≤ 5 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week can be included in the study at the discretion of the PI or designee if willing to abstain during inpatient stay.
• Body mass index (BMI) \>18.0 and \<32.0 kg/m2 at Screening and body weight ≥50.0 kg and ≤ 120.0 kg.
• Is judged by the Investigator to be in generally good health based on medical history, physical examination, vital sign parameters, ECG, laboratory parameters, and other relevant tests conducted at Screening.
• Pulse between 50 and 100 beats per minute (bpm), inclusive at Screening.
• Systolic blood pressure (BP) between 100 and 140 mmHg, diastolic BP between 50 and 90 mmHg inclusive, at Screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once.
• No known allergic reaction to cannabis products (including tetrahydrocannabinol \[THC\], CBD, marijuana, and hashish) or EPIDIOLEX®.
• Must have hepatic and renal clinical laboratory test results (total bilirubin and estimated glomerular filtrate rate \[eGFR\] by the CKD-EPI \[2021\] equation) within a laboratory defined normal range at Screening. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designers.
• Females must not be pregnant, lactating, or planning pregnancy, and if they are a woman of childbearing potential (WOCBP), must use acceptable, highly effective contraception from Screening until 93 days (90 days + approximately 5 half-lives) after the last IP administration. Effective forms of contraception are defined in Section 7.2.2. Females with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle. Women of childbearing potential must have a negative serum hCG pregnancy test at Screening and negative urine test on Day -1. Women not of childbearing potential must be postmenopausal for ≥ 12 months (postmenopausal status is to be confirmed through testing of follicle-stimulating hormone \[FSH\] levels ≥ 40 IU/L at Screening for amenorrhoeic female participants), or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
• Male participants who are sexually active with WOCBP must meet any of the following criteria:
• Vasectomy for at least 6 months prior to enrolment and willing and able to use a condom.
• Willing and able to use one of highly effective contraception methods.
• Male participants with pregnant partners are not eligible.
• Male participants must be willing not to donate sperm throughout the study and for 93 days (90 days + approximately 5 half-lives) after the last dose of IP.

You may not qualify if:

• History of any clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine (including type 2 diabetes), oncologic, pulmonary, immunologic, or cardiovascular disease or other condition which could jeopardize safety or impact validity of results at the discretion of the PI.
• Has any documented clinically significant infection, injury, or illness within 1 month prior to Screening.
• Has any documented history of, or currently active, seizure disorder or history of clinically significant head injury.
• Has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin).
• Any laboratory test results deemed clinically significant by the PI (clinically significant results may be repeated once at discretion of the investigator) or positive test for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
• Positive COVID-19 polymerase chain reaction (PCR) test results at Day -1.
• History of inherent cardiac abnormalities at the discretion of the PI.
• Clinically significant ECG abnormalities (Fridericia's corrected QT interval \[QTcF\] \>450 msec for males and \>470 msec for females), PR \>210 msec, QRS interval \>120 msec at Screening (clinically significant results may be repeated once at discretion of the investigator).
• ALT, AST, total cholesterol, LDL-C, or triglycerides \>1.5 × the upper limit of normal (ULN) at Screening. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designees.
• Known allergic reactions to any excipient in the IP formulations.
• History of significant drug abuse such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to Screening.
• Use of marijuana or THC (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
• Positive screen for urine drug, urine cotinine (Day -1 only), or breath alcohol test at Screening or Day -1 (positive results may be repeated once at discretion of the investigator).
• History of significant alcohol abuse within 1 year prior to Screening or regular use of alcohol within 6 months prior to Screening that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of 40% distilled alcohol).
• Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety (eg, topical drug products without significant systemic absorption):

Sponsors & Collaborators

• Indication Bioscience LLC: lead

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

MeSH Terms

Conditions

Coronary Disease; Dyslipidemias

Interventions

26S proteasome non-ATPase regulatory subunit 13

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• James E Smeeding

  President, Indication Biosciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: January 28, 2025
• Primary Completion: May 14, 2025
• Study Completion: June 10, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

AU (1)