Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants

NCT ID: NCT05134350

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2020-03-23

Brief Summary

The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment Sequence 1: ABC

• Period 1: Single oral dose of 200 milligram (mg) LOXO-305 (Fasted state) on Day 1 (Treatment A)
• Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B)
• Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)

A washout period of 7 days was maintained between each treatment period.

Group Type: EXPERIMENTAL

LOXO-305

Intervention Type: DRUG

LOXO-305 orally.

Omeprazole

Intervention Type: DRUG

Omeprazole Orally.

Treatment Sequence 2: BAC

• Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B)
• Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A)
• Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)

A washout period of 7 days was maintained between each treatment period.

Group Type: EXPERIMENTAL

LOXO-305

Intervention Type: DRUG

LOXO-305 orally.

Omeprazole

Intervention Type: DRUG

Omeprazole Orally.

Interventions

LOXO-305

LOXO-305 orally.

Intervention Type: DRUG

Omeprazole

Omeprazole Orally.

Intervention Type: DRUG

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 25-night stay 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), and Sponsor.
• 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) through the end of the 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), 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-JZNH

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-BTK-20014

Identifier Type: -

Identifier Source: org_study_id