A Study of LY2495655 in Healthy Subjects

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single IV dose LY2495655	LY2495655	Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
Multiple SC dose 140 mg LY2495655	LY2495655	140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Single IV dose placebo	Placebo	Single Placebo dose administered intravenously (IV)
Multiple SC dose 17.5 mg LY2495655	LY2495655	17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
Multiple SC dose 420 mg LY2495655	LY2495655	420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses)
Multiple SC dose placebo	Placebo	Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Effects	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 Outcome Measures

Name	Time	Method
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	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.
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	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.

A Study of LY2495655 in Healthy Subjects

Recruitment & Eligibility

Study & Design

Trial Locations

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