A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single and Multiple Doses of Pirtobrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Loxo Oncology, Inc.
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Study Overview
Brief Summary
The main purpose of this study is to determine the effect of pirtobrutinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with pirtobrutinib in healthy participants. This study will last up to approximately 26 days excluding screening period.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs.
- •Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per meter squared (kg/m²) and a body weight of at least 50 kg.
- •Males, or female participants who are not of childbearing potential.
Exclusion Criteria
- •Have known allergies to pirtobrutinib or rosuvastatin, related compounds, or any components of the formulation.
- •Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator.
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorder or surgery (including cholecystectomy) capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
- •Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, and/or herbal medications), or modulators of CYP3A4 or BCRP within 7 days prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- •Have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined through genotyping.
- •Have c.521TC and c/521CC genotypes of SLCO1B1 as determined by genotyping.
Arms & Interventions
Rosuvastatin + Pirtobrutinib
Participants received study intervention through oral administration as follows:
- Day 1: 20 milligram (mg) rosuvastatin alone
- Day 6: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
- Days 7 to 12: Once daily (QD) doses of 200 mg pirtobrutinib alone
- Day 13: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
- Days 14 to 17: QD doses of 200 mg pirtobrutinib alone.
Intervention: Rosuvastatin (Drug)
Rosuvastatin + Pirtobrutinib
Participants received study intervention through oral administration as follows:
- Day 1: 20 milligram (mg) rosuvastatin alone
- Day 6: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
- Days 7 to 12: Once daily (QD) doses of 200 mg pirtobrutinib alone
- Day 13: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
- Days 14 to 17: QD doses of 200 mg pirtobrutinib alone.
Intervention: Pirtobrutinib (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Time Frame: Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose.
PK: Cmax of Rosuvastatin
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin
Time Frame: Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose.
PK: AUC(0-inf) of Rosuvastatin
Secondary Outcomes
No secondary outcomes reported