CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Treprostinil +3 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Overtly healthy Japanese subjects
  • ✓Body mass index (BMI) 18.5 - 25 kg/m²
  • ✓Fasting plasma glucose ≥71 mg/dL and <108 mg/dL (Part B only)
  • ✓Normal blood pressure, pulse rate, ECG, blood and urine laboratory test results acceptable for study
Key exclusion· 4
  • ✕Currently enrolled in another clinical trial with investigational product or incompatible medical research
  • ✕Participated in clinical trial with investigational product within 30 days before study entry
  • ✕Previously completed or withdrawn from this study or other studies investigating treprostinil or LY900014, or previously received investigational product
  • ✕Health problems, abnormal laboratory results, or ECG findings that could make participation unsafe or interfere with study results interpretation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02770521
NCT02770521Phase 1Completed
CompareCT.gov

A Study to Evaluate the Safety and Tolerability of Subcutaneous Treprostinil and Pharmacokinetics of a Novel LY900014 Formulation in Healthy Japanese Subjects

Eli Lilly and Company·interventional·Posted May 12, 2016·Updated Jun 4, 2020

In Brief

A Phase 1 clinical trial evaluating Treprostinil, Placebo, and 2 other interventions for Healthy. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 12, 2016
Enrollment StartMay 1, 2016
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.1 years ago

Interventions

Treprostinildrug

Administered SC.

Placebodrug

Administered SC.

LY900014drug

Administered SC.

Insulin Lisprodrug

Administered SC.