A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin

NCT06081166 | Completed Phase 1 FDA Drug

• 1 other identifier: TA-8995-11
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate impact of Obicetrapib on PK levels of Atorvastatin and Rosuvastatin

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Measure atorvastatin/rosuvastatin levels in the blood

  Measure atorvastatin/rosuvastatin concentrations via various analytical methods

  zero (0) to time of the last measurable analyte concentration (t), up to 22 days

Study Arms (2)

obicetrapib + atorvastatin

ACTIVE COMPARATOR

Obicetrapib 10 mg tablets daily from Days 1-17 plus atorvastatin calcium 80 mg tablets on Day -4 and Day 12

Drug: Obicetrapib; Drug: Atorvastatin Calcium

obicetrapib + rosuvastatin

ACTIVE COMPARATOR

Obicetrapib 10 mg tablets daily from Days 1-17 plus rosuvastatin calcium 40 mg tablets on Day -4 and Day 12

Drug: Obicetrapib; Drug: Rosuvastatin Calcium

Interventions

Obicetrapib DRUG

obicetrapib 10 mg daily

Also known as: tablets

obicetrapib + atorvastatin; obicetrapib + rosuvastatin

Atorvastatin Calcium DRUG

Atorvastatin 80 mg

Also known as: tablets

obicetrapib + atorvastatin

Rosuvastatin Calcium DRUG

Rosuvastatin 40 mg

Also known as: tablets

obicetrapib + rosuvastatin

Eligibility Criteria

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

You may qualify if:

• Cohort 1 Healthy, non-smoking, male and female subjects, from 18 to 65 years of age Cohort 2 Healthy, non-smoking, male and female subjects of non-Asian origin, 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:
• o 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:

• Known history or presence 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.
• Known history or presence of hypersensitivity or idiosyncratic reaction to atorvastatin, rosuvastatin, obicetrapib, or any other drug substances with similar activity.
• Known history or presence of chronic infectious disease, system disorders, organ dysfunction especially hypothyroidism, stroke or transient ischemic attack, myopathy, rhabdomyolysis, renal or hepatic disorders, diabetes, or obesity which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
• Subjects of Asian origin (Cohort 2 only).
• 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 consuming standard meals.
• Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
• Females who:
• Have used implanted, injected, intravaginal, or intrauterine hormonal contraceptives within 6 months prior to drug administration;

Sponsors & Collaborators

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

Study Sites (1)

Mark M Feldman

Toronto, Ontario, M1S 3V6, Canada

Location

Related Publications (1)

• Kastelein JJP, Ditmarsch M, Hsieh A, Kling D, Walker A, Dicklin MR, Tayab Z, Bouhajib M, Davidson MH. A Drug-Drug Interaction Study Evaluating the Pharmacokinetic Consequences of Obicetrapib Therapy on Atorvastatin or Rosuvastatin Levels in Healthy Volunteers. Am J Cardiovasc Drugs. 2025 Sep;25(5):693-702. doi: 10.1007/s40256-025-00740-1. Epub 2025 Jun 26.

  PMID: 40569335 DERIVED

MeSH Terms

Interventions

Tablets; Atorvastatin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

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: October 3, 2023
• First Posted: October 13, 2023
• Study Start: November 11, 2023
• Primary Completion: December 2, 2023
• Study Completion: January 22, 2024
• Last Updated: May 22, 2025

Record last verified: 2023-10

Locations

CA (1)