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A study to evaluate impact of Obicetrapib on PK levels of Atorvastatin and Rosuvastatin
Full 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
Enrollment
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Inclusion criteria
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:
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
Exclusion criteria
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:
Donation or loss of whole blood (including clinical trials):
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.
On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
Have had a tattoo or body piercing within 30 days prior to drug administration.
Have clinically significant findings in vital signs measurements.
Have clinically significant findings in a 12-lead ECG.
Have clinically significant abnormal laboratory values.
Have significant diseases.
Have clinically significant findings from a physical examination.
Use of any of the following within 30 days prior to drug administration:
Primary purpose
Allocation
Interventional model
Masking
74 participants in 2 patient groups
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Central trial contact
Mark M Feldman
Data sourced from clinicaltrials.gov
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