Phase 1
Completed N=47
A Study of LY2495655 in Healthy Subjects
Healthy Volunteer
Source: ClinicalTrials.gov NCT01341470 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Number of Participants With Clinically Significant Effects — 0; 0; 7; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Effects |
0; 0; 7; 4; 0; 2 | — |
| SECONDARY Pharmacokinetics, Maximum Concentration (Cmax) |
192; 8.11; 102; 303; 23.8; 304 | — |
| SECONDARY Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC) |
50.5; 2.32; 24.0; 79.8; 6.82; 88.7 | — |
| SECONDARY Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax) |
0.58; 168; 168; 167; 48.0; 96.0 | — |
| SECONDARY Percentage Change in Thigh Muscle Volume |
0.30; 0.40; 1.51; 1.80; NA; -1.15 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01341470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.