Clinical trial NCT05176314: A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2022-01-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
timeFrame: 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.
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: QPS Bio-Kinetic Clinical Applications
state: Missouri
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: