JPRN-jRCT2080223225
Unknown
Phase 1
A Study to Evaluate the Safety and Tolerability of Subcutaneous Treprostinil and Pharmacokinetics of a Novel LY900014 Formulation in Healthy Japanese Subjects (I8B-JE-ITRK)
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Eli Lilly Japan K.K.
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •Overtly healthy Japanese
- •Body mass index (BMI) 18\.5 \- 25 kilograms per square meter (kg/m2\)
- •Fasting plasma glucose \>\=71 milligrams per deciliter (mg/dL) (3\.9 millimoles per liter \[mmol/L]) and \<108 mg/dL (6\.0 mmol/L) (Part B only)
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
Exclusion Criteria
- •Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have participated in a clinical trial involving an investigational product within the 30 days before study entry
- •Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Outcomes
Primary Outcomes
Not specified
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