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Study of Galunisertib in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02752919
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Galunisertib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Part A Galunisertib - 1 tablet
Single oral dose of galunisertib in Japanese participants
Drug: Galunisertib
Administered orally
Other Name: LY2157299

Experimental: Part A Galunisertib - 2 tablets
Single oral dose of galunisertib in Japanese participants
Drug: Galunisertib
Administered orally
Other Name: LY2157299

Experimental: Part B Galunisertib - 1 tablet
Single oral dose of galunisertib in non-Japanese participants
Drug: Galunisertib
Administered orally
Other Name: LY2157299

Experimental: Part B Galunisertib - 2 tablets
Single oral dose of galunisertib in non-Japanese participants
Drug: Galunisertib
Administered orally
Other Name: LY2157299




Primary Outcome Measures :
  1. Estimated Change from Baseline in Fridericia-corrected QT Interval (QTcF) by Specific Galunisertib Concentrations [ Time Frame: Baseline through 72 hours after administration of study drug ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Drug Concentration (Cmax) of Galunisertib [ Time Frame: Predose through 72 hours after administration of study drug ]
  2. Pharmacokinetics: Time of Cmax (tmax) of Galunisertib [ Time Frame: Predose through 72 hours after administration of study drug ]
  3. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Galunisertib [ Time Frame: Predose through 72 hours after administration of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752919


Locations
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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, United Kingdom
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02752919    
Other Study ID Numbers: 16214
H9H-MC-JBEI ( Other Identifier: Eli Lilly and Company. )
2015-005261-23 ( EudraCT Number )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: June 2016