Study of Galunisertib in Healthy Participants

NCT02752919 | Completed Phase 1

• 3 other identifiers: 16214H9H-MC-JBEI2015-005261-23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Estimated Change from Baseline in Fridericia-corrected QT Interval (QTcF) by Specific Galunisertib Concentrations

  Baseline through 72 hours after administration of study drug

Secondary Outcomes (3)

• 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

Study Arms (4)

Part A Galunisertib - 1 tablet

EXPERIMENTAL

Single oral dose of galunisertib in Japanese participants

Drug: Galunisertib

Part A Galunisertib - 2 tablets

EXPERIMENTAL

Single oral dose of galunisertib in Japanese participants

Drug: Galunisertib

Part B Galunisertib - 1 tablet

EXPERIMENTAL

Single oral dose of galunisertib in non-Japanese participants

Drug: Galunisertib

Part B Galunisertib - 2 tablets

EXPERIMENTAL

Single oral dose of galunisertib in non-Japanese participants

Drug: Galunisertib

Interventions

Galunisertib DRUG

Administered orally

Also known as: LY2157299

Part A Galunisertib - 1 tablet; Part A Galunisertib - 2 tablets; Part B Galunisertib - 1 tablet; Part B Galunisertib - 2 tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Leeds, West Yorkshire, United Kingdom

Location

MeSH Terms

Interventions

LY-2157299

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2016-06

Locations

GB (1)