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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)

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)

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223225
Enrollment
Unknown
Registered
2016-06-01
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Interventions

investigational material(s) Generic name etc : Treprostinil INN of investigational material : Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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clinical trial involving an investigational product within the 30 days before study entry Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product Have or used to have health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

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026