NCT06615284

A Study of Atorvo+™ in Healthy Adult Participants

A Phase 1 Randomized, Single-Blind, Three-Arm, Staggered Parallel Study to Assess the Safety, Tolerability, and Pharmacokinetics of Atorvo+™ in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Indication Bioscience LLC · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Coronary Heart Disease
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Atorvo+™ (Arm1)	Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).
DRUG	Atorvo+™ +CBD (Arm 2)	Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).
DRUG	Atorvo+™ +CBD (Arm 3)	Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-05-14
• Completion: 2025-06-10
• First posted: 2024-09-26
• Last updated: 2025-12-19

Locations

1 site across 1 country: Australia