A Study of LY2623091 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Tadalafil; Drug: Diltiazem; Drug: Simvastatin; Drug: LY2623091; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02300259

15523

I7T-MC-RMAG (Other Identifier)

Details and patient eligibility

About

The first purpose of this study is to evaluate the effect of itraconazole (and possibly diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get rid of it.

The second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.

The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.

There will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants as determined by medical history, physical examination, clinical laboratory tests, and electrocardiograms (ECGs).
• Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m^2) inclusive, at screening
• Female participants must be of non-childbearing potential

Exclusion criteria

• In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 8 patient groups

LY2623091 (Group 1)

Experimental group

Description:

LY2623091 administered orally once on Day 1 of Period 1.

Treatment:

Drug: LY2623091

Itraconazole + LY2623091 (Group 1)

Experimental group

Description:

200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2.

Treatment:

Drug: LY2623091

Drug: Itraconazole

Simvastatin (Group 2)

Experimental group

Description:

20 mg simvastatin administered orally once daily on Day 1.

Treatment:

Drug: Simvastatin

LY2623091 + Simvastatin (Group 2)

Experimental group

Description:

LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12.

Treatment:

Drug: Simvastatin

Drug: LY2623091

Tadalafil (Group 3)

Experimental group

Description:

5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.

Treatment:

Drug: Tadalafil

Tadalafil + LY2623091 (Group 3)

Experimental group

Description:

LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2.

Treatment:

Drug: Tadalafil

Drug: LY2623091

LY2623091 (Group 4)

Experimental group

Description:

LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.

Treatment:

Drug: LY2623091

Diltiazem + LY2623091 (Group 4)

Experimental group

Description:

240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2.

Treatment:

Drug: Diltiazem

Drug: LY2623091