A Study of the Effects of Pirtobrutinib (LOXO-305) on Repaglinide (CYP2C8 Substrate) in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2020-12-30

Brief Summary

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The main purpose of this study is to evaluate the effect of pirtobrutinib (LOXO-305) on single oral dose of repaglinide (CYP2C8 substrate) when administered as multiple doses by conducting the blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) in adult healthy participants. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). The study is conducted in two periods. Participants will stay in this study for up to 54 days.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Period 1: 0.5 mg Repaglinide

Participants received a single oral dose of 0.5 milligrams (mg) repaglinide tablet, in the morning on Day 1.

Group Type EXPERIMENTAL

Repaglinide

Intervention Type DRUG

Administered orally.

Period 2: 200 mg Pirtobrutinib QD

Participants received oral doses of 200 mg pirtobrutinib tablets, once daily (QD) in the morning from Day 2 to Day 11.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally.

Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide

Participants received oral doses of 200 mg pirtobrutinib QD and 0.5 mg repaglinide tablets, in the morning on Day 12.

Group Type EXPERIMENTAL

Repaglinide

Intervention Type DRUG

Administered orally.

Pirtobrutinib

Intervention Type DRUG

Administered orally.

Interventions

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Repaglinide

Administered orally.

Intervention Type DRUG

Pirtobrutinib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LOXO-305 LY3527727

Eligibility Criteria

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Inclusion Criteria

* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
* Must have comply with all study procedures, including the 16-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion Criteria

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes