Safety and Activity of Oral HPBCD in Coronary Artery Disease

Phase 2

Completed

• Conditions: Coronary Artery Disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12622001377729
• Lead Sponsor: PPD part of Thermo Fisher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-26
• Study Completion: 2023-02-22
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed
consent form (ICF).
2. Has a documented history of stable (>3 months prior to screening) coronary heart disease (at least 1 of the following):
-Acute coronary syndrome or myocardial infarction.
-Coronary revascularization procedure.
-Diagnosis of coronary heart disease based on anatomic or functional test results.
3. Any antihypertensives, glucose- or lipid-lowering medications, or hormone therapies must have been taken as a stable dose for at least 4 weeks prior to screening.
4. Body mass index within the range of 18.5 to 35 kg/m2 (inclusive) and body weight less than or equal to 140kg.
5. Male participants are eligible if they agree to all of the following requirements during the study intervention period and for at least 30 days after the last dose of study drug:
-Refrain from donating sperm; AND
-Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) or agree to utilize highly effective contraception
6. Female participants are eligible if they meet all of the following requirements during the study intervention period and for at least 30 days after the last dose of study drug:
-Refrain from donating eggs (ova, oocytes) for the purpose of reproduction.
-Meet at least one of the following criteria:
+Is not a woman of childbearing potential (WOCBP); OR
+Is a WOCBP, has a negative serum pregnancy test within 24 hours before the first dose of study drug, and agrees to utilize highly effective contraception.
7. Is capable of understanding the ICF, has provided signed and witnessed informed consent, and agreed to comply with the protocol requirements.

Exclusion Criteria

1. History of any significant cardiac event or procedure within 3 months prior to Screening, including:
-Acute coronary syndrome or myocardial infarction
-Coronary revascularization procedure
-Clinically significant electrocardiogram (ECG) abnormalities, including but not limited to conduction abnormalities or atrial fibrillation
2. Insulin-dependent diabetes mellitus Type 1 or Type 2, or hemoglobin A1c lower than or equal to 9.5%
3. Systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100 mmHg despite antihypertensive medication
4. Donation or loss of blood greater than or equal to 450 mL within 8 weeks prior to screening
5. Clinically significant laboratory abnormalities, including:
-Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 × upper limit of normal (ULN)
-Total bilirubin > 1.5 × ULN
-Fasting serum triglycerides greater than or equal to 500 mg/dL
-LDL cholesterol lower than or equal to 40 mg/dL
-HDL cholesterol > 80 mg/dL
-Hemoglobin < 11.0 g/dL
-Platelet count < 150,000/µL
-Thyroid-stimulating hormone (TSH) > 1.5 × ULN
6. Any physical or psychiatric condition which at the Investigator’s discretion may put the
participant at risk, may confound the trial results, or may interfere with participation in
this clinical trial.
7. The participant is pregnant or breastfeeding.
8. History of any malignancy (other than basal cell carcinoma of the skin or in situ cervical
cancer) within the past 5 years.
9. Cognitive, psychological, or addictive conditions (including alcoholism or drug/ chemical abuse) that, in the opinion of the Investigator, may interfere with participant compliance,put the participant at risk, or preclude informed consent.
10. Current use of bile acid sequestrants or cholesterol absorption inhibitors (for example, ezetimibe).
11. Current enrollment or past participation in another investigational study in which an investigational intervention (for example, drug, vaccine, and invasive device) was administered within 30 days or 5 half-lives, whichever is longer, of screening in this clinical study.
12. Positive blood screen for hepatitis B surface antigen or core antibody, hepatitis C antibody, or human immunodeficiency virus 1 or 2 antibodies.
13. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins (thyroid replacement therapy can be included if on stable dose for at least 12 weeks prior to screening and TSH level is within normal limits).
14. Planned surgery or coronary angiography/intervention during the time of study participation; any major surgery within 6 weeks of screening, or surgical or medical condition which might jeopardize participant’s safety.
15. Sensitivity to the study drug, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified