Phase 1
Completed N=11
A Study of LY2835219 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02327143 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219 — 3730; 15.4 nanogram*h/milliliter (ng∙h/mL)
Summary
The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle).
The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function.
The study will last about 10 days. Screening is required within 28 days before study drug is given.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219 |
3730; 15.4 | — |
| SECONDARY PK: Maximum Observed Concentration (Cmax) of LY2835219 |
114 | — |
| SECONDARY PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219 |
6.63 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy sterile males or surgically sterile females or postmenopausal females
- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)
- Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
- Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria
- Have participated in a clinical trial involving investigational product within the last 90 days
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure
- Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Data sourced from ClinicalTrials.gov (NCT02327143). 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.