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

NCT06050291 | Completed Phase 1 FDA Drug

• 1 other identifier: OBEZ-103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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/10 mg in healthy adult male and female subjects under fasted and fed conditions.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum measured plasma concentration following each treatment.

  528.00 hours

• AUC0-t

  Area under the plasma concentration versus time curve from time zero to the time of the last measurable plasma concentration, as calculated by linear trapezoidal method.

  528.00 hours

• AUC0-∞

  Area under the plasma concentration versus time curve from time zero to infinity where AUC0-∞ = AUC0-t + Ct/λz. Ct is the last measurable concentration and λz is the terminal rate constant.

  528.00 hours

Secondary Outcomes (8)

• Tmax

  528.00 hours

• Tlag

  528.00 hours

• λz

  528.00 hours

• t½

  528.00 hours

• CL/F

  528.00 hours

Study Arms (2)

FDC Tablet Fed + Fast

EXPERIMENTAL

Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fed condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fasted condition after, at a minimum, a 56 day washout.

Drug: Fixed-Dose Combination (FDC) Tablet

FDC Tablet Fast + Fed

EXPERIMENTAL

Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fasted condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fed condition after, at a minimum, a 56 day washout.

Drug: Fixed-Dose Combination (FDC) Tablet

Interventions

Fixed-Dose Combination (FDC) Tablet DRUG

Obicetrapib/Ezetimibe FDC tablet

FDC Tablet Fast + Fed; FDC Tablet Fed + Fast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (1)

NOVUM

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Single-Dose, Randomized, Two-Treatment, Two-Period, Two-Sequence, Crossover Study

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 22, 2023
• Study Start: January 20, 2024
• Primary Completion: April 7, 2024
• Study Completion: April 7, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)