Clinical trial NCT01354496: A Study of LY2409021 Formulations and the Effect of Food
Official title: LY2409021 Formulation Bridging and Food Effect Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Bioavailability
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


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

Primary outcomes:
measure: Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form
timeFrame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
measure: Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form
timeFrame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Secondary outcomes:
measure: Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting
timeFrame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
measure: Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting
timeFrame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
measure: Pharmacokinetics, Time to Maximum Concentration (Tmax)
timeFrame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
measure: Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size
timeFrame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
measure: Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size
timeFrame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your person physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: