Completed

A Phase I, Single-Dose, Randomized, Partially Double-Blind, Placebo- and Positive-Controlled, 3-Way Crossover Study to Evaluate the Effect of LOXO-305 on QTc Interval in Healthy Subjects

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What is being tested

Pirtobrutinib

+ Placebo

+ Moxifloxacin

Drug
Who is being recruted

From 18 to 55 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1
Interventional
Study Start: December 2020
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 15, 2020

Actual date on which the first participant was enrolled.

This clinical trial is exploring the effects of a drug called Pirtobrutinib, also known as LOXO-305, on the heart's electrical activity specifically focusing on a part called the QTc interval. It aims to understand how the drug influences this aspect of heart function and to measure the amount of the drug in the bloodstream. The study involves healthy participants to ensure that the effects seen are solely due to the drug. This research is crucial as it helps in determining the safety of the drug and understanding how the body processes it, which is essential before it can be used to treat patients with specific conditions. Participants in the study will receive a single dose of Pirtobrutinib and undergo various tests, including blood tests, to monitor the drug's presence in their bodies. The study is set up in a way that compares the effects of the drug with a placebo and a known positive control to ensure accurate results. Participants will be under observation to assess any changes in their heart function and to determine the drug's safety and how well it is tolerated. The entire study, including the initial screening phase, will last up to 71 days, ensuring comprehensive monitoring and evaluation.

Official TitleA Phase I, Single-Dose, Randomized, Partially Double-Blind, Placebo- and Positive-Controlled, 3-Way Crossover Study to Evaluate the Effect of LOXO-305 on QTc Interval in Healthy Subjects
NCT06215521
Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive at Screening
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 15-night stay at the Clinical Research Unit (CRU) and follow-up phone call
6 exclusion criteria prevent from participating
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
Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Pirtobrutinib a single oral dose on Day 1, 12 and 23 following a fast of at least 8 hours prior to and 6 hours after dosing.

Group II

Placebo
Placebo (matched to Pirtobrutinib) a single oral dose on Day 1, 12 and 23 following a fast of at least 8 hours prior to and 6 hours after dosing.

Group III

Active Comparator
Moxifloxacin a single oral dose on Day 1, 12 and 23 following a fast of at least 8 hours prior to and 6 hours after dosing.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Covance Clinical Research Unit 1341 Mockingbird Lane

Dallas, United StatesOpen Covance Clinical Research Unit 1341 Mockingbird Lane in Google Maps
Suspended

Covance Clinical Research Unit 3402 Kinsman Blvd

Madison, United States
Completed2 Study Centers