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HealthyPhase 1NCT02575703

A Study of [¹⁴C]-LY3023414 in Healthy Participants

A Phase 1 study testing [¹⁴C]-LY3023414 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This type of study is called a radiolabeled study. For this study, LY3023414 has been specially prepared to contain the radioactive carbon atom [¹⁴C]. [¹⁴C] is a naturally occurring radioactive form of the element carbon. 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?
[¹⁴C]-LY3023414
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Oct 2015to Nov 2015
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

  • Healthy men or women
  • Male participants: Will be sterile (including vasectomy), confirmed by documentation. Men who are sexually active with a pregnant partner agree to use a condom for 91 days from the time of dosing
  • Female participants: Women not of childbearing potential due to surgical sterilization (at least 6 months after hysterectomy with or without bilateral oophorectomy or at least 6 months after tubal ligation) confirmed by medical history or menopause. Postmenopausal women include women with spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (eg, oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) and a follicle-stimulating hormone level greater than 40 milli international units per milliliter (mIU/mL)
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter square (kg/m²)
  • Have clinical laboratory test results within normal reference range for the population or investigator site
  • Have venous access sufficient to allow for blood sampling

Who cannot join

  • Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous [¹⁴C]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe: Less than 5000 millirem (mrem)/year whole body exposure.
  • Exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
  • Are participants who have previously completed or withdrawn from this study or any other study investigating LY3023414, and have previously received the investigational product
  • Have known allergies to LY3023414, related compounds, or any components of the formulation
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug testing
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show all 15Show fewer
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Intend to use over-the-counter or prescription medication within 7 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, or are unwilling to stop alcohol consumption from 48 hours prior to admission and while resident in the Clinical Research Unit (CRU)
  • Have consumed herbal supplements, grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruit or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
  • Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until discharge from the CRU
  • Have a defecation pattern less than once per day or acute constipation within 3 weeks prior to admission
  • Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Inc

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: Disposition of [¹⁴C]-LY3023414 Following Oral Administration in Healthy Subjects

This type of study is called a radiolabeled study. For this study, LY3023414 has been specially prepared to contain the radioactive carbon atom [¹⁴C]. [¹⁴C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study drug does not change how the drug works but helps to identify when the drug appears in the blood, urine, breath, and stool after it is given. The study will last about 15 days for each participant, not including screening. Screening is required within 28 days prior to enrollment. This study is for research purposes only and is not intended to treat any medical condition.

Conditions
Healthy
Being tested
[¹⁴C]-LY3023414

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [¹⁴C]-LY3023414Drug

    LY3023414 in solution containing approximately 100 microCi [¹⁴C]-LY3023414

Study groups in NCT02575703
Study groupRoleWhat they receive
[¹⁴C]-LY3023414ExperimentalSingle oral dose of [¹⁴C]-LY3023414 administered on Day 1
Receives: Drug: [¹⁴C]-LY3023414

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary Excretion of LY3023414 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Measured: Baseline up to 144 hours postdose

  2. Fecal Excretion of LY3023414 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Measured: Baseline up to 144 hours postdose

Secondary outcomes (4)

  1. Plasma Pharmacokinetics of LY3023414 and Radioactivity Maximum Observed Concentration (Cmax)

    Measured: Baseline up to 144 hours postdose

  2. Plasma Pharmacokinetics of LY3023414 and Radioactivity Time of Maximum Observed Concentration (Tmax)

    Measured: Baseline up to 144 hours postdose

  3. Plasma Pharmacokinetics of LY3023414 and Radioactivity Area Under the Concentration Versus Time Curve (AUC)

    Measured: Baseline up to 144 hours postdose

  4. Relative Abundance of LY3023414 and the Metabolites of LY3023414 as Measured by Percentage of Sample Radioactivity in Plasma, Feces, Urine

    Measured: Baseline up to 144 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02575703
Sponsor's protocol ID
15697
Other IDs
I6A-EW-CBBC
Status last verified
Nov 2015
First submitted
5 Oct 2015
Last updated
23 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [¹⁴C]-LY3023414 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

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 6 inclusion and 15 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 23 Nov 2015. 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 States. 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?

Urinary Excretion of LY3023414 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Baseline up to 144 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02575703.

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 23 Nov 2015.

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