HealthyPhase 1NCT02752919
Study of Galunisertib in Healthy Participants
A Phase 1 study testing Galunisertib in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Galunisertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
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
About this study
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
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
- Being tested
- Galunisertib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalunisertibDrug
Also called LY2157299
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A Galunisertib - 1 tablet | Experimental | Single oral dose of galunisertib in Japanese participants Receives: Drug: Galunisertib |
| Part A Galunisertib - 2 tablets | Experimental | Single oral dose of galunisertib in Japanese participants Receives: Drug: Galunisertib |
| Part B Galunisertib - 1 tablet | Experimental | Single oral dose of galunisertib in non-Japanese participants Receives: Drug: Galunisertib |
| Part B Galunisertib - 2 tablets | Experimental | Single oral dose of galunisertib in non-Japanese participants Receives: Drug: Galunisertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Change from Baseline in Fridericia-corrected QT Interval (QTcF) by Specific Galunisertib Concentrations
Measured: Baseline through 72 hours after administration of study drug
Secondary outcomes (3)
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Galunisertib
Measured: Predose through 72 hours after administration of study drug
Pharmacokinetics: Time of Cmax (tmax) of Galunisertib
Measured: Predose through 72 hours after administration of study drug
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Galunisertib
Measured: Predose through 72 hours after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752919
- Sponsor's protocol ID
- 16214
- Other IDs
- H9H-MC-JBEI, 2015-005261-23, 2015
- Status last verified
- Jun 2016
- First submitted
- 26 Apr 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02752919
- Acronym / sponsor ID
- 16214
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Galunisertib - 1 tablet | Experimental | Drug: GalunisertibSingle oral dose of galunisertib in Japanese participants |
| Part A Galunisertib - 2 tablets | Experimental | Drug: GalunisertibSingle oral dose of galunisertib in Japanese participants |
| Part B Galunisertib - 1 tablet | Experimental | Drug: GalunisertibSingle oral dose of galunisertib in non-Japanese participants |
| Part B Galunisertib - 2 tablets | Experimental | Drug: GalunisertibSingle oral dose of galunisertib in non-Japanese participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalunisertibAlso: LY2157299Administered orally | Drug | Part A Galunisertib - 1 tablet, Part A Galunisertib - 2 tablets, Part B Galunisertib - 1 tablet, Part B Galunisertib - 2 tablets |
Primary outcome
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
3 secondary outcomes
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Galunisertib
Time frame: Predose through 72 hours after administration of study drug
Pharmacokinetics: Time of Cmax (tmax) of Galunisertib
Time frame: Predose through 72 hours after administration of study drug
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Galunisertib
Time frame: Predose through 72 hours after administration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Galunisertib in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.