Phase 1
Completed N=23
A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants
Healthy
Source: ClinicalTrials.gov NCT02770521 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 participants
Summary
The aims of this study are to evaluate:
* The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
* The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.
The study has two parts. Participants may only enroll in one part.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B) |
582; 956; 2170 | — |
| PRIMARY PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B) |
174; 273; 585 | — |
| SECONDARY PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A) |
0.25 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of Treprostinil (Part A) |
0.0271 | — |
Eligibility 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- Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product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
Data sourced from ClinicalTrials.gov (NCT02770521). 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.