Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe

• Status: Active, not recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NewAmsterdam Pharma

Criteria

Key Inclusion Criteria:

• Males and Females aged 18 to 65.

• Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive.

• Females of childbearing potential must be willing to use approved method of birth control.

• Blood pressure 90/60 - 140/90 mmHg, inclusive.

• Hemoglobin level above lower limit of normal.

• Good health.

Key Exclusion Criteria:

• Females who are pregnant, lactating or likely to become pregnant during the study.

• History of allergy, sensitivity to obicetrapib, ezetimibe or any components of the study products, or history of any drug hypersensitivity or intolerance that may compromise the safety of the subject.

• Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction especially hypothyroidism, renal or hepatic disorders, cardiovascular disorders, respiratory disorders, diabetes or obesity.

• Clinically significant history or presence of gastrointestinal disease or history of malabsorption within the last year.

• History of psychiatric disorders occurring within the last two years that required the subject to be hospitalized or treated with medication.

• Presence of a medical condition requiring regular treatment with prescription drugs.

• Use of statins, cyclosporine, fibrates (e.g., fenofibrate), bile acid seuqstrants (e.g., cholestyramine), or coumarin anticoagulants within 30 days before initial dosing.

• Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes (especially inducers and inhibitors of CYP3A4) within 30 days before initial dosing.

• Use of any drug that can alter the absorption of other drugs by affecting gastrointestinal motility or by changing the gastric pH, in the opinion of the Investigator, within 14 days before initial dosing.

• Use of any drug that can increase or decrease the metabolism and excretion of the study drug, within 14 days before initial dosing.

• Receipt of any drug as part of a research study within 30 days before initial dosing.

• Previous participation in a research study with obicetrapib.

• Drug or alcohol addiction requiring treatment in the 12 months before initial dosing.

• History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.

• Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days before initial dosing.

• Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.

• Positive test results for drugs of abuse at screening.

• If female, has a positive pregnancy test at screening.

• Use of tobacco- or nicotine-containing products within 30 days before initial dosing.

• Difficulty swallowing tablets or capsules whole.