AzTrials
AzTrials

Healthy VolunteerPhase 1NCT01341470

A Study of LY2495655 in Healthy Subjects

A Phase 1 study testing LY2495655 in people with Healthy Volunteer, 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
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects. Read more about this study

Who is it for?
Ages 24 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
LY2495655
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
1 siteUnited States
Study dates
May 2011to May 2012
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 24 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Single dose cohort
  • Overtly healthy males or females, as determined by medical history and physical examination
  • Between the ages of 24 and 50 years
  • Multiple dose cohorts
  • Sedentary males and females with stable medical problems, if any, that, in the investigator's opinion, will not place the subject at increased risk by participating in the study and will not interfere with interpretation of the data
  • Between the ages of 50 and 85 years
Show all 14Show fewer
  • Score <600 Metabolic Equivalent Tasks (METs) per week based on International Physical Activity Questionnaire (IPAQ)
  • All subjects
  • Male subjects: agree to use a reliable method of birth control
  • Female subjects: women not of child-bearing potential due to surgical sterilization (at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history, or menopause
  • Up to third generation Japanese, that is defined as all of the subject's biological grandparents are of exclusive Japanese descent and have been born in Japan
  • Are ambulatory and able to perform a stair climb test
  • Have clinical laboratory tests within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Have venous access sufficient to allow for blood sampling and/or administration of investigational product for intravenous administration

Who cannot join

  • Single dose cohort
  • Intend to use over the counter or prescription medication within 14 days prior to dosing through 2 months after dosing except for thyroid replacement hormones or non-absorbed topical preparations per investigator instructions
  • Abnormal supine blood pressure defined as diastolic blood pressure > 90 millimeters of mercury (mmHg) and/or systolic blood pressure >140 mmHg
  • Multiple dose cohort
  • If taking medications, subjects who have not been stable for at least 3 months, or the time required to produce stable effects of the drug
  • Abnormal supine blood pressure defined as >100 mmHg and/or systolic blood pressure >160 mmHg
Show all 20Show fewer
  • All subjects
  • Have known allergies to LY2495655, related compounds or any components of the formulation
  • Have a history or presence of cardiovascular, respiratory (including moderate to severe restrictive lung disease and obstructive disease, chronic bronchitis, and those with symptomatic asthma), hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of constituting a risk when taking the study medication or of interfering with the interpretation of data
  • Have a history of seizures or convulsions, excluding febrile convulsions in childhood
  • Subjects with underlying muscle disease or a history of muscle disease (for example, polymyositis or rhabdomyolysis)
  • Evidence or recent history of significant active psychiatric disease such as schizophrenia, depression, or bipolar disorder
  • Recent immobilization or major trauma to the legs within 6 months
  • Knee or hip replacement or lower extremity amputation
  • Participate in, or have participated within 3 months of study drug administration, a regular resistance training program or plan to participate in an exercise program during the study
  • Actively working in a physically demanding profession
  • Have contraindications for the Magnetic Resonance Imaging (MRI) scan
  • Tattoos on the right leg if the tattoos are at least 20 years old and may have iron-containing pigments
  • Electrocardiogram (ECG) considered outside the normal limits for the study population by the investigator and relevant for interpretation or indicating cardiac disease
  • Clinically significant abnormality in neurologic or neurocognitive examinations at screening

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.

    Honolulu, Hawaii, 96814

Other trials in United States

About this study

Official title: A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2495655 in Japanese Subjects

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.

Being tested
LY2495655, Placebo

What participants receive

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

  • LY2495655Drug

    administered intravenously or subcutaneously

  • PlaceboDrug

    administered intravenously or subcutaneously

Study groups in NCT01341470
Study groupRoleWhat they receive
Single IV dose LY2495655ExperimentalSingle 70 milligram (mg) dose LY2495655 administered intravenously (IV)
Receives: Drug: LY2495655
Multiple SC dose 17.5 mg LY2495655Experimental17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Receives: Drug: LY2495655
Multiple SC dose 140 mg LY2495655Experimental140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Receives: Drug: LY2495655
Multiple SC dose 420 mg LY2495655Experimental420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Receives: Drug: LY2495655
Single IV dose placeboPlacebo comparatorSingle Placebo dose administered intravenously (IV)
Receives: Drug: Placebo
Multiple SC dose placeboPlacebo comparatorPlacebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Receives: Drug: Placebo

What is being measured

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

  1. Number of Participants With Clinically Significant Effects

    Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.

    Measured: Baseline to study completion (up to 135 days)

Secondary outcomes (4)

  1. Pharmacokinetics, Maximum Concentration (Cmax)

    Measured: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose

  2. Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC)

    Area under the concentration curve (AUC) time zero to infinity (0-inf) was calculated for single dose administration and AUCtau (AUCτ) at steady state was calculated for multiple dose administration.

    Measured: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose

  3. Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)

    Measured: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose

  4. Percentage Change in Thigh Muscle Volume

    Thigh muscle volume was determined by Magnetic Resonance Imaging (MRI) scan of the right leg thigh muscle. Percentage change in thigh muscle volume=(time point value-baseline value)*100. Change from baseline for muscle volume was analyzed using mixed model repeated measures (MMRM) model with fixed effects of treatment, time and treatment*time interaction and a random effect of subject where baseline values were included as a covariate.

    Measured: Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose arms

Timeline

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

  1. First posted25 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

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
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01341470
Sponsor's protocol ID
14270
Other IDs
I1Q-JE-JDDH
Status last verified
Mar 2019
First submitted
20 Apr 2011
Last updated
17 Jun 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2495655 in people with Healthy Volunteer, 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 14 inclusion and 20 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 17 Jun 2019. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Clinically Significant Effects (time frame: Baseline to study completion (up to 135 days)). 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 NCT01341470.

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 17 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in