Status:
COMPLETED
Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe
Lead Sponsor:
NewAmsterdam Pharma
Conditions:
Healthy Volunteer Study
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is an open-label, single-dose, randomized, two-treatment, two-period, two-sequence crossover relative bioavailability study under fasted and fed conditions. It will assess the effect of food on t...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
January 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06050291
Start Date
January 20 2024
End Date
April 7 2024
Last Update
June 5 2024
Active Locations (1)
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1
NOVUM
Las Vegas, Nevada, United States, 89121