A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05176314
• Other study ID #: 18366
• Secondary ID: J2N-MC-JZNW
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2022
• Est. completion date: March 23, 2022

Study information

• Verified date: April 1, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Rosuvastatin
Administered Orally.
• Pirtobrutinib
Administered Orally.

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas
United States	QPS Bio-Kinetic Clinical Applications	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Loxo Oncology, Inc.	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin	PK: Cmax of Rosuvastatin	Pre-dose up to 120 hours post-dose
Primary	PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin	PK: AUC(0-inf) of Rosuvastatin	Pre-dose up to 120 hours post-dose