A Study of LY2495655 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01341470
First received: April 20, 2011
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: LY2495655
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2495655 in Japanese Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: baseline to study completion (estimate of 8 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: baseline, days 1, 2, 3, 8, 15, 22, 29, 43, 57 and 85 for single dose arms/baseline, days 1, 2, 3, 5, 8, 12, 15, 22, 29, 43, 57, 58, 59, 61, 64, 71, 85 and 127 for multiple dose arms ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the concentration versus time curve (AUC) [ Time Frame: baseline, days 1, 2, 3, 8, 15, 22, 29, 43, 57 and 85 for single dose arms/baseline, days 1, 2, 3, 5, 8, 12, 15, 22, 29, 43, 57, 58, 59, 61, 64, 71, 85 and 127 for multiple dose arms ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time of maximum observed drug concentration (tmax) [ Time Frame: baseline, days 1, 2, 3, 8, 15, 22, 29, 43, 57 and 85 for single dose arms/baseline, days 1, 2, 3, 5, 8, 12, 15, 22, 29, 43, 57, 58, 59, 61, 64, 71, 85 and 127 for multiple dose arms ] [ Designated as safety issue: No ]
  • Change in thigh muscle volume [ Time Frame: baseline, days 22 for a single dose arm/ baseline, days 22 and 71 for multiple dose arms ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose LY2495655
Single 70 mg dose LY2495655 administered intravenously
Drug: LY2495655
administered intravenously or subcutaneously
Experimental: Multiple dose 17.5 mg LY2495655
17.5 mg of LY2495655 administered subcutaneously every 2 weeks for 8 weeks (total of 5 doses)
Drug: LY2495655
administered intravenously or subcutaneously
Experimental: Multiple dose 140 mg LY2495655
140 mg of LY2495655 administered subcutaneously every 2 weeks for 8 weeks (total 5 doses)
Drug: LY2495655
administered intravenously or subcutaneously
Experimental: Multiple dose 420 mg LY2495655
420 mg dose of LY2495655 administered subcutaneously every 2 weeks for 8 weeks (total 5 doses)
Drug: LY2495655
administered intravenously or subcutaneously
Placebo Comparator: Single dose placebo
single dose administered intravenously
Drug: Placebo
administered intravenously or subcutaneously
Placebo Comparator: Multiple dose placebo
subcutaneous dose administered subcutaneously every 2 weeks for 8 weeks (total of 5 doses)
Drug: Placebo
administered intravenously or subcutaneously

  Eligibility

Ages Eligible for Study:   24 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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
    • 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

Exclusion Criteria:

  • 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 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
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341470

Locations
United States, Hawaii
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, United States, 96814
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01341470     History of Changes
Other Study ID Numbers: 14270, I1Q-JE-JDDH
Study First Received: April 20, 2011
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014