Clinical trial NCT06081166: A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin
Official title: A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: NewAmsterdam Pharma
Sponsor class: INDUSTRY
Collaborators: name: Pharma Medica Research, Inc.
First posted: 2023-10-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Open-label, two-cohort, fixed sequence, drug-drug interaction study
Primary purpose: TREATMENT

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

Detailed description: A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects

Eligibility criteria: Inclusion Criteria:

1. 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
2. BMI ≥18.5 and ≤30 kg/m2
3. 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).
4. Willing to use acceptable, effective methods of contraception.
5. Able to tolerate venipuncture.
6. Be informed of the nature of the study and give written consent prior to any study procedure

Exclusion Criteria:

1. 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.
2. Known or suspected carcinoma.
3. Known history or presence of hypersensitivity or idiosyncratic reaction to atorvastatin, rosuvastatin, obicetrapib, or any other drug substances with similar activity.
4. 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.
5. Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
6. Subjects of Asian origin (Cohort 2 only).
7. History of malabsorption within the last year or presence of clinically significant gastrointestinal (GI) disease.
8. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
9. History of drug or alcohol addiction requiring treatment.
10. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
11. Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
12. Difficulty consuming standard meals.
13. Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
14. Females who:

    * Have used implanted, injected, intravaginal, or intrauterine hormonal contraceptives within 6 months prior to drug administration;
    * Have used oral or transdermal hormonal contraceptives within 21 days prior to drug administration;
    * Are pregnant (serum hCG consistent with pregnancy); or
    * Are breast-feeding.
15. Donation or loss of whole blood (including clinical trials):

    * ≥50 mL and \<500 mL within 30 days prior to drug administration;
    * ≥500 mL within 56 days prior to drug administration.
16. Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
17. On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
18. Have had a tattoo or body piercing within 30 days prior to drug administration.
19. Have clinically significant findings in vital signs measurements.
20. Have clinically significant findings in a 12-lead ECG.
21. Have clinically significant abnormal laboratory values.
22. Have significant diseases.
23. Have clinically significant findings from a physical examination.
24. Use of any of the following within 30 days prior to drug administration:

    * Anticoagulants
    * Anti-fungals (e.g., voriconazole, itraconazole)
    * Anti-virals
    * Capmatinib
    * Cholestyramine
    * Colchicine
    * Cyclosporine
    * Darolutamide
    * Digoxin
    * Drugs known to induce/inhibit hepatic drug metabolism or alter GI pH/movement (e.g., omeprazole, ranitidine)
    * Fostamatinib
    * Inducers and inhibitors of CYP3A4
    * Inducers and inhibitors of breast cancer resistant protein
    * Inducers and inhibitors of OATP1B1/OATP1B3
    * Inducers and inhibitors of P-glycoprotein)
    * Macrolide antibiotic medications (e.g., erythromycin)
    * Niacin
    * Regorafenib
    * Statins
    * Tafamidis
    * Teriflunomide
    * Drugs that decrease levels of endogenous steroid hormones (e.g., ketoconazole, spironolactone, cimetidine)
    * Febuxostat
    * Fibrates (e.g., fenofibrate, gemfibrozil)
    * Warfarin

Primary outcomes:
measure: Measure atorvastatin/rosuvastatin levels in the blood
timeFrame: zero (0) to time of the last measurable analyte concentration (t), up to 22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mark M Feldman
state: Ontario
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Mark M Feldman
role: PRINCIPAL_INVESTIGATOR
References: