Phase 1
Completed N=24
A Study of LY2835219 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02059148 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms — 111; 137 nanogram/milliliter (ng/mL)
Summary
Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms |
111; 137 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms |
4160; 4790 | — |
| PRIMARY Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms |
8.00; 10.00 | 0.0006 sig |
| SECONDARY Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm |
141 | — |
| SECONDARY Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm |
4610 | — |
| SECONDARY Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm |
8.00 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20) |
3590; 3320; 3510 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy sterile males or surgically sterile or postmenopausal females
- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
- Are able to eat a high-fat, high-calorie meal
Exclusion Criteria
- Participated in a clinical trial involving investigational product within 30 days
- Abnormal blood pressure
- 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 donated blood of more than 500 milliliter (mL) within the last month
- Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C
Data sourced from ClinicalTrials.gov (NCT02059148). 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.