Study of Galunisertib in Healthy Participants

A Single Dose Study to Evaluate the Exposure-Response Relationship Between Galunisertib (LY2157299) and QT Interval in Healthy Japanese and Non-Japanese Subjects

The study involves a single dose of galunisertib taken by mouth by Japanese participants and non-Japanese participants. The study will evaluate the relationship between the effect of the study drug on the electrical activity of the heart, as measured by electrocardiogram (ECG) and how much of the study drug gets into the blood stream and how long it takes the body to remove it. Ths study will last about 42 days for each participant.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Galunisertib

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination.
• Male participants: Must agree to use a reliable method of birth control for 12 weeks after receiving the dose of study drug, OR be at least 6 weeks post-vasectomy with documentation of sperm-free ejaculate.

• Female participants: Women not of child-bearing potential may participate, and include those who are:

  • Infertile due to surgical sterilization; or
  • Postmenopausal.
• All female participants must test negative for pregnancy at screening.
• Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²), inclusive at screening.
• Have clinical laboratory test results within normal reference range.
• Are able and willing to give signed informed consent.

Exclusion Criteria:

• Have participated, within the last 3 months, in a clinical trial involving an Investigational Product (IP). If the previous IP has a long half-life, 3 months should have passed.
• Have known allergies to galunisertib-related compounds or any components of the formulation, or history of significant atopy.
• Have a personal or family history of long QT syndrome, heart failure, hypokalemia, or sudden death.
• Have a personal history of unexplained syncope within the last year.
• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the corrected QT (QTc) analysis (the ECG waveform morphology or rhythm are incompatible with reliable measurement of ECG intervals), or have QTcF greater than (>) 450 milliseconds (msec).
• Have an abnormal blood pressure as determined by the investigator.
• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the IP; or of interfering with the interpretation of data.
• Have serum magnesium and potassium values outside of the normal reference range.
• Show evidence of human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B.
• Intend to use over-the-counter or prescription medication (including herbal medications) within 14 days prior to dosing.
• Have donated blood of more than 500 milliliter (mL) within the last month
• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Galunisertib - 1 tablet; Single oral dose of galunisertib in Japanese participants	Drug: Galunisertib; Administered orally; Other Names: LY2157299
Experimental: Part A Galunisertib - 2 tablets; Single oral dose of galunisertib in Japanese participants	Drug: Galunisertib; Administered orally; Other Names: LY2157299
Experimental: Part B Galunisertib - 1 tablet; Single oral dose of galunisertib in non-Japanese participants	Drug: Galunisertib; Administered orally; Other Names: LY2157299
Experimental: Part B Galunisertib - 2 tablets; Single oral dose of galunisertib in non-Japanese participants	Drug: Galunisertib; Administered orally; Other Names: LY2157299

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimated Change from Baseline in Fridericia-corrected QT Interval (QTcF) by Specific Galunisertib Concentrations	Baseline through 72 hours after administration of study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Galunisertib	Predose through 72 hours after administration of study drug
Pharmacokinetics: Time of Cmax (tmax) of Galunisertib	Predose through 72 hours after administration of study drug
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Galunisertib	Predose through 72 hours after administration of study drug

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 16214 (Other Identifier: REB); H9H-MC-JBEI (Other Identifier: Eli Lilly and Company.); 2015-005261-23 (EudraCT Number)