Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants

NCT ID: NCT05134337

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2020-10-30

Brief Summary

The main purpose of this study is to learn about how itraconazole and rifampin affect LOXO-305 in healthy participants. Participation could last about 8 weeks.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1 (LOXO-305/Itraconazole)

• Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
• Day 8: oral doses of 200 mg itraconazole was administered twice daily.
• Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.

Group Type: EXPERIMENTAL

LOXO-305

Intervention Type: DRUG

Oral LOXO-305

Itraconazole

Intervention Type: DRUG

Oral itraconazole

Part 2 (LOXO 305/Rifampin)

• Day 1: a single oral dose of 200 mg LOXO-305 was administered.
• Days 8 to 23: oral dose of 600 mg rifampin was administered once daily, and on Days 8 & 17, it was co-administered with a single oral dose of 200 mg LOXO-305.

Group Type: EXPERIMENTAL

LOXO-305

Intervention Type: DRUG

Oral LOXO-305

Rifampin

Intervention Type: DRUG

Oral rifampin

Interventions

LOXO-305

Oral LOXO-305

Intervention Type: DRUG

Itraconazole

Oral itraconazole

Intervention Type: DRUG

Rifampin

Oral rifampin

Intervention Type: DRUG

Other Intervention Names

Pirtobrutinib

Eligibility Criteria

Inclusion Criteria

• Males and females of non-childbearing potential.
• Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
• Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
• Able to comply with all study procedures, including the 19-night stay for those participating in Part 1 or 24-night stay for those participating in Part 2 at the Clinical Research Unit and follow-up phone call.

Exclusion Criteria

• History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

• liver disease
• pancreatitis
• peptic ulcer disease
• intestinal malabsorption
• gastric reduction surgery
• history or presence of clinically significant cardiovascular disease.
• Participants with out-of-range, at-rest vital signs.
• Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
• Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
• Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
• Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
• History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
• Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
• Receipt of blood products within 2 months prior to Check-in (Day -1).
• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renée Ward, MD, PhD

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

Covance Clinical Research Unit

Daytona Beach, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2N-OX-JZNC

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-BTK-20006

Identifier Type: -

Identifier Source: org_study_id