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

NCT05176314 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18366J2N-MC-JZNW
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin

  PK: Cmax of Rosuvastatin

  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: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin

  PK: AUC(0-inf) of Rosuvastatin

  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.

Study Arms (1)

Rosuvastatin + Pirtobrutinib

EXPERIMENTAL

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.

Drug: Rosuvastatin; Drug: Pirtobrutinib

Interventions

Rosuvastatin DRUG

Administered Orally.

Rosuvastatin + Pirtobrutinib

Pirtobrutinib DRUG

Administered Orally.

Also known as: LY3527727

Rosuvastatin + Pirtobrutinib

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loxo Oncology, Inc.: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

QPS Bio-Kinetic Clinical Applications

Springfield, Missouri, 65802, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; pirtobrutinib

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 4, 2022
• Study Start: January 11, 2022
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)