Study of Galunisertib in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752919
• Other study ID #: 16214
• Secondary ID: H9H-MC-JBEI2015-
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2016
• Last updated: June 30, 2016
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Galunisertib
Administered orally

Locations

Country	Name	City	State
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.	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Change from Baseline in Fridericia-corrected QT Interval (QTcF) by Specific Galunisertib Concentrations		Baseline through 72 hours after administration of study drug	No
Secondary	Pharmacokinetics: Maximum Drug Concentration (Cmax) of Galunisertib		Predose through 72 hours after administration of study drug	No
Secondary	Pharmacokinetics: Time of Cmax (tmax) of Galunisertib		Predose through 72 hours after administration of study drug	No
Secondary	Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Galunisertib		Predose through 72 hours after administration of study drug	No