A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2495655 in Japanese Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Number of Participants With Clinically Significant Effects
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 24 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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 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
- •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
Arms & Interventions
Single IV dose LY2495655
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
Intervention: LY2495655 (Drug)
Multiple SC dose 17.5 mg LY2495655
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Intervention: LY2495655 (Drug)
Multiple SC dose 140 mg LY2495655
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Intervention: LY2495655 (Drug)
Multiple SC dose 420 mg LY2495655
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Intervention: LY2495655 (Drug)
Single IV dose placebo
Single Placebo dose administered intravenously (IV)
Intervention: Placebo (Drug)
Multiple SC dose placebo
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Clinically Significant Effects
Time Frame: Baseline to study completion (up to 135 days)
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.
Secondary Outcomes
- 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)
- 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)
- Percentage Change in Thigh Muscle Volume(Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose arms)
- 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)