CBD in Postmenopausal Women With Osteopenia

Study Overview
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Brief Summary
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This is a Phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of CHI-554 in postmenopausal women ages 50-80 years who have osteopenia.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Preliminary Effects of CHI-554 in Postmenopausal Women With Osteopenia

Conditions
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Osteopenia

Intervention / Treatment
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* Drug: CBD
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a female aged 50-80 years, inclusive, at the time of screening. Is postmenopausal, defined as > or = 12 months amenorrhoea. Has osteopenia, defined as T score at lumbar spine or femoral neck or total femur of less than -1.0, but not less than or equal to -2.5, according to dual energy x-ray absorptiometry (DXA) completed at the Screening Visit or performed at NM Clinical Research & Osteoporosis Center up to 6 months prior to the Screening Visit. Has been on a stable dose of 500 mg calcium daily for at least 7 days prior to Visit 1. Has a body mass index between 18 and 35 kg/m2 (inclusive). Is judged by the Investigator to be in generally good health at screening based on participants' medical history. Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening. Exclusion Criteria: Has a history of epilepsy, hepatitis, or human immunodeficiency virus. Current or history of use of one or more prohibited medications (as described in Section 8.2.1.1). Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the 4 weeks prior to the Screening Visit. Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal (ULN), or bilirubin >2× ULN. Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP. Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides). Has taken grapefruit products and/or Seville oranges within the 7 days prior to Visit 1. Positive urine dipstick results for THC at the Screening Visit. Has a history or current diagnosis of a significant psychiatric disorder, including alcohol or substance use disorder, that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements. Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol. History of Osteoporosis diagnosis.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - 100 mg CBD<br>100 mg CBD per day | Drug: CBD<br>* CBD<br>|
| Experimental: Group B - 300 mg CBD<br>300 mg CBD per day | Drug: CBD<br>* CBD<br>|
| Placebo Comparator: Group C - Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability: Adverse Events/Serious Adverse Events | Adverse Events/Serious Adverse Events | Week 4 | 
| Safety and Tolerability: Adverse Events/Serious Adverse Events | Adverse Events/Serious Adverse Events | Week 8 | 
| Safety and Tolerability: Adverse Events/Serious Adverse Events | Adverse Events/Serious Adverse Events | Week 12 | 
| Safety and Tolerability: Alanine aminotransferase (ALT) | Alanine aminotransferase | Week 4 | 
| Safety and Tolerability: Alanine aminotransferase (ALT) | Alanine aminotransferase | Week 12 | 
| Safety and Tolerability: Aspartate aminotransferase (AST) | Aspartate aminotransferase | Week 4 | 
| Safety and Tolerability: Aspartate aminotransferase (AST) | Aspartate aminotransferase | Week 12 | 
| Safety and Tolerability: Total bilirubin | Total bilirubin | Week 4 | 
| Safety and Tolerability: Total bilirubin | Total bilirubin | Week 12 | 
| Safety and Tolerability: Blood pressure | Blood pressure - Systolic and diastolic blood pressure | Week 4 | 
| Safety and Tolerability: Blood pressure | Blood pressure - Systolic and diastolic blood pressure | Week 12 | 
| Safety and Tolerability: Heart rate | Heart rate | Week 4 | 
| Safety and Tolerability: Heart rate | Heart rate | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum CTx | Serum CTx | Week 4 | 
| Serum CTx | Serum CTx | Week 12 | 
| Serum P1NP | Serum P1NP | Week 4 | 
| Serum P1NP | Serum P1NP | Week 12 | 
| Serum Osteocalcin | Serum Osteocalcin | Week 4 | 
| Serum Osteocalcin | Serum Osteocalcin | Week 12 | 
| Serum Bone-specific alkaline phosphatase | Serum Bone-specific alkaline phosphatase | Week 4 | 
| Serum Bone-specific alkaline phosphatase | Serum Bone-specific alkaline phosphatase | Week 12 |