A Study of LY2495655 in Healthy Subjects

NCT01341470 | Completed Phase 1 Results

• 2 other identifiers: 14270I1Q-JE-JDDH
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (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.

  Baseline to study completion (up to 135 days)

Secondary Outcomes (4)

• Pharmacokinetics, Maximum Concentration (Cmax)

  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

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

  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

• Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)

  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

• Percentage Change in Thigh Muscle Volume

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

Study Arms (6)

Single IV dose LY2495655

EXPERIMENTAL

Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)

Drug: LY2495655

Multiple SC dose 17.5 mg LY2495655

EXPERIMENTAL

17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)

Drug: LY2495655

Multiple SC dose 140 mg LY2495655

EXPERIMENTAL

140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)

Drug: LY2495655

Multiple SC dose 420 mg LY2495655

EXPERIMENTAL

420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)

Drug: LY2495655

Single IV dose placebo

PLACEBO COMPARATOR

Single Placebo dose administered intravenously (IV)

Drug: Placebo

Multiple SC dose placebo

PLACEBO COMPARATOR

Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)

Drug: Placebo

Interventions

LY2495655 DRUG

administered intravenously or subcutaneously

Multiple SC dose 140 mg LY2495655; Multiple SC dose 17.5 mg LY2495655; Multiple SC dose 420 mg LY2495655; Single IV dose LY2495655

Placebo DRUG

administered intravenously or subcutaneously

Multiple SC dose placebo; Single IV dose placebo

Eligibility Criteria

• Age: 24 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, United States

Location

MeSH Terms

Interventions

landogrozumab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 25, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-03

Locations

US (1)