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Healthy VolunteersPhase 1NCT01746004

A Study of LY2157299 Monohydrate in Healthy Volunteers

A Phase 1 study testing [^14C]-LY2157299 in people with Healthy Volunteers, 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 study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
[^14C]-LY2157299
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
Jan 2013to Feb 2013
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy surgically sterile females, postmenopausal females, or sterile males
  • Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)
  • Have venous access sufficient to allow for blood sampling

Who cannot join

  • Have known allergies to LY2157299, related compounds or any components of the formulation
  • Have an abnormal blood pressure as determined by the investigator
  • Have participated in a [^14C]-study within the last 6 months prior to admission for this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects

This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. This study is approximately 8 to 15 days.

Being tested
[^14C]-LY2157299

What participants receive

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

  • [^14C]-LY2157299Drug

    [^14C]-LY2157299 monohydrate administered as oral solution

Study groups in NCT01746004
Study groupRoleWhat they receive
[^14C]-LY2157299ExperimentalSingle 150 mg oral dose of LY2157299 monohydrate containing 100 micro curies of [^14C] labeled drug
Receives: Drug: [^14C]-LY2157299

What is being measured

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

  1. Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Measured: Pre-dose through Day 15

Secondary outcomes (5)

  1. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)

    Measured: Pre-dose through Day 14

  2. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)

    Measured: Pre-dose through Day 14

  3. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Area Under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast)

    Measured: Pre-dose through Day 14

  4. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces

    Measured: Pre-dose through Day 14

  5. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma

    Measured: Pre-dose through Day 14

Timeline

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

  1. First posted10 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746004
Sponsor's protocol ID
14671
Other IDs
H9H-MC-JBAM
Status last verified
Feb 2013
First submitted
6 Dec 2012
Last updated
15 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [^14C]-LY2157299 in people with Healthy Volunteers, 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 3 inclusion and 3 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 15 Feb 2013. 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 and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Pre-dose through Day 15). 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 NCT01746004.

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 15 Feb 2013.

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