Phase 1
N=29
A Study of LY900014 Formulations in Healthy Participants
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02317575 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) — 1720; 1740; 1810; 1750 picomol times hour per liter (pmol*h/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY900014 (Biological); Insulin Lispro (Biological)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) |
1720; 1740; 1810; 1750; 1690 | — |
| SECONDARY Part A: Visual Analog Scale (VAS) Score for Injection Site Pain |
0.1; 2.1; 1.8; 1.3; 0.5; 0 | — |
| SECONDARY Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp |
78372; 81776; 82365; 80186; 75571 | — |
| SECONDARY Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability |
— | — |
| SECONDARY Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability |
— | — |
Summary
This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen. The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability were documented. The study was to be conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last for about 11 to 12 weeks, including screening and follow up. Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.
Eligibility Criteria
Inclusion Criteria
- Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
- Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
Exclusion Criteria
- Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- 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 (NCT02317575). 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.