Phase 1
Completed N=35
A Study of LY2409021 Formulations and the Effect of Food
Healthy Volunteers
Source: ClinicalTrials.gov NCT01354496 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form — 65300; 62800 nanograms*hour per milliliter (ng*hr/mL)
Summary
The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.
The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.
There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form |
65300; 62800 | — |
| PRIMARY Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form |
779; 726 | — |
| SECONDARY Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting |
67000; 65300 | — |
| SECONDARY Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting |
785; 779 | — |
| SECONDARY Pharmacokinetics, Time to Maximum Concentration (Tmax) |
8.00; 8.00; 8.00; 4.00; 8.00; 8.00 | — |
| SECONDARY Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size |
73700; 69400; 73600 | — |
| SECONDARY Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size |
835; 793; 844 | — |
Eligibility Criteria
Inclusion Criteria
- Must be healthy male or a healthy female who cannot become pregnant
- Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
- Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
- The veins must be suitable for easy blood collection
- Must be willing to be available for the whole study and be willing to follow study procedures
Exclusion Criteria
- Were in another new drug or medical research study in the last 30 days
- Have previously taken part in this study or any other study with LY2409021
- Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
- Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
- Electrocardiogram (ECG) readings are not suitable for the study
- Are infected with hepatitis B
- Are infected with human immunodeficiency disease virus (HIV)
- Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
- Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- Have a history of drug or alcohol abuse
- Have donated 450 milliliters (mL) or more of blood in the last 3 months
- Are unwilling or unable to comply with dietary requirements/restrictions during the study
- The study doctor thinks the participant should not participate for any other reasons
Data sourced from ClinicalTrials.gov (NCT01354496). 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.