A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

NCT06547359 | Completed Phase 1 FDA Drug

• 1 other identifier: TA-8995-14
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Cmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  Maximum measured analyte concentration

  time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days

• AUCt (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  The area under the analyte concentration versus time curve

  time zero (0) to the time of the last measurable analyte concentration (t)

• AUCinf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  The area under the analyte concentration versus time curve

  m time zero to infinity

Secondary Outcomes (5)

• Tmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  zero (0) to the time of the last measurable analyte concentration (t), up to 18 days

• Kel (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days

• Thalf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  zero (0) to the time of the last measurable analyte concentration (t), up to 18 days

• CL/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days

• Vd/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)

  time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days

Study Arms (2)

obicetrapib with and without co-administration of ezetimibe

ACTIVE COMPARATOR

Ezetimibe 10mg tablets daily from Days 1-17 plus obicetrapib 10mg tablets on Day -9 and Day 8

Drug: Obicetrapib 10mg; Drug: Ezetimibe 10mg

ezetimibe with and without co-administration of obicetrapib

ACTIVE COMPARATOR

Obicetrapib 10mg tablets daily from Days 1-15 plus ezetimibe10mg tablets on Day -3 and Day 12

Drug: Obicetrapib 10mg; Drug: Ezetimibe 10mg

Interventions

Obicetrapib 10mg DRUG

tablets

ezetimibe with and without co-administration of obicetrapib; obicetrapib with and without co-administration of ezetimibe

Ezetimibe 10mg DRUG

tablets

ezetimibe with and without co-administration of obicetrapib; obicetrapib with and without co-administration of ezetimibe

Eligibility Criteria

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

You may qualify if:

• Healthy, non-smoking, male and female subjects, from 18 to 65 years of age.
• BMI ≥18.5 and ≥30 kg/m2
• Females may be of childbearing or non-childbearing potential. Childbearing potential (physically capable of becoming pregnant). Non-childbearing potential: Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause and FSH and LH values consistent with being postmenopausal).
• Willing to use acceptable, effective methods of contraception.
• Able to tolerate venipuncture.
• Be informed of the nature of the study and give written consent prior to any study procedure.

You may not qualify if:

• History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Known or suspected carcinoma.
• History of hypersensitivity or idiosyncratic reaction to obicetrapib, ezetimibe, or any other drug substances with similar activity.
• History of clinically significant angioedema.
• History of myopathy, rhabdomyolysis, or myalgia, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• History of pancreatitis, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• History of severe cutaneous adverse reactions (SCARs), Steven-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilic and systemic symptoms (DRESS), which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Presence of hepatic or renal dysfunction.
• History of malabsorption within the last year or presence of clinically significant gastrointestinal (GI) disease.
• Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
• History of drug or alcohol addiction requiring treatment.
• Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
• Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
• Difficulty fasting or consuming standard meals.
• Use of tobacco or nicotine-containing products within six (6) months prior to the first drug administration.

Sponsors & Collaborators

• NewAmsterdam Pharma: lead
• Pharma Medica Research, Inc.: collaborator

Study Sites (1)

PharmaMedica Research Inc.

Toronto, Ontario, M1S 3V6, Canada

Location

MeSH Terms

Interventions

Ezetimibe

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark M Feldman

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open-label, two-cohort, fixed-sequence, drug-drug interaction study

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: October 1, 2024
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

CA (1)