A Study of LY2409021 Formulations in Healthy Participants

Lilly

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: LY2409021

Study type: Interventional

Funder types: Industry

Identifiers

NCT02385084

I1R-MC-GLDM (Other Identifier)

15709

Details and patient eligibility

About

The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
• Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)
• Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion criteria

• Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
• 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 known or ongoing psychiatric disorders

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 5 patient groups

Part A: LY2409021 Capsule

Experimental group

Description:

Single oral dose of LY2409021 capsule in one of three study periods.

Treatment:

Drug: LY2409021

Part A: LY2409021 Tablet Pre-commercial

Experimental group

Description:

Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods.

Treatment:

Drug: LY2409021

Part A: LY2409021 Tablet Commercial

Experimental group

Description:

Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods.

Treatment:

Drug: LY2409021

Part B: LY2409021 Capsule

Experimental group

Description:

Single oral dose of LY2409021 capsule in one of two study periods.

Treatment:

Drug: LY2409021

Part B: LY2409021 Tablet Commercial

Experimental group

Description:

Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.

Treatment:

Drug: LY2409021