A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2020-12-01

Brief Summary

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The main purpose of this study is to assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 46 days, including screening.

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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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1: 300 mg Pirtobrutinib

Participants received a single dose of Pirtobrutinib 300 milligram (mg) administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally.

Cohort 2: 600 mg Pirtobrutinib

Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally.

Cohort 3: 800 mg Pirtobrutinib

Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally.

Cohort 4: 900 mg Pirtobrutinib

Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally.

Interventions

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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 8-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

* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening
* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening or Check-in (Day -1)
* 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)
* Have previously completed or withdrawn from any other study investigating Pirtobrutinib (LOXO-305) and have previously received the investigational product

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes