A Study of LY2409021 Formulations and the Effect of Food

NCT01354496 | Completed Phase 1 Results

• 2 other identifiers: 14194I1R-FW-GLBQ
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Bioavailability

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form

  AUC from time 0 to infinity (AUC0-∞).

  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)

• Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form

  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 (5)

• Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting

  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)

• Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting

  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)

• Pharmacokinetics, Time to Maximum Concentration (Tmax)

  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)

• Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size

  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)

• Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size

  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)

Study Arms (6)

Cohort 1 - LY2409021 reference form

EXPERIMENTAL

A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state

Drug: LY2409021 Reference Form

Cohort 1 - LY2409021 medium test form fed

EXPERIMENTAL

Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal

Drug: LY2409021 Test-Med Formulation (medium particle size)

Cohort 1 - LY2409021 medium test form fasted

EXPERIMENTAL

Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state

Drug: LY2409021 Test-Med Formulation (medium particle size)

Cohort 2 - LY2409021 low test form fasted

EXPERIMENTAL

Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state

Drug: LY2409021 Test-Low Formulation (low particle size)

Cohort 2 - LY2409021 medium test form fasted

EXPERIMENTAL

Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state

Drug: LY2409021 Test-Med Formulation (medium particle size)

Cohort 2 - LY2409021 high test form fasted

EXPERIMENTAL

Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state

Drug: LY2409021 Test-High Formulation (high particle size)

Interventions

LY2409021 Reference Form DRUG

Administered orally

Cohort 1 - LY2409021 reference form

LY2409021 Test-Med Formulation (medium particle size) DRUG

Administered orally

Cohort 1 - LY2409021 medium test form fasted; Cohort 1 - LY2409021 medium test form fed; Cohort 2 - LY2409021 medium test form fasted

LY2409021 Test-High Formulation (high particle size) DRUG

Administered orally

Cohort 2 - LY2409021 high test form fasted

LY2409021 Test-Low Formulation (low particle size) DRUG

Administered orally

Cohort 2 - LY2409021 low test form fasted

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Singapore, Singapore

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 17, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 11, 2019
• Results First Posted: March 11, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)