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A Study of LY2623091 in Healthy Participants

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: LY2623091 (Drug); Itraconazole (Drug); Simvastatin (Drug); Tadalafil (Drug); Diltiazem (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company


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.

Clinical Details

Official title: A Study to Determine the Effect of CYP3A Inhibition on the Pharmacokinetics of LY2623091 and the Effect of LY2623091 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2623091 and Cytochrome (CYP) P450 Substrates

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY2623091 and Cytochrome (CYP) P450 Substrates


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


Locations and Contacts

Covance Clinical Research Inc, Daytona Beach, Florida 32117, United States
Additional Information

Starting date: November 2014
Last updated: April 16, 2015

Page last updated: August 23, 2015

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