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A Study of LY2623091 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02300259
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY2623091 Drug: Itraconazole Drug: Simvastatin Drug: Tadalafil Drug: Diltiazem Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: LY2623091 (Group 1)
LY2623091 administered orally once on Day 1 of Period 1.
Drug: LY2623091
Administered orally

Experimental: Itraconazole + LY2623091 (Group 1)
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.
Drug: LY2623091
Administered orally

Drug: Itraconazole
Administered orally

Experimental: Simvastatin (Group 2)
20 mg simvastatin administered orally once daily on Day 1.
Drug: Simvastatin
Administered orally

Experimental: LY2623091 + Simvastatin (Group 2)
LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12.
Drug: LY2623091
Administered orally

Drug: Simvastatin
Administered orally

Experimental: Tadalafil (Group 3)
5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.
Drug: Tadalafil
Administered orally

Experimental: Tadalafil + LY2623091 (Group 3)
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.
Drug: LY2623091
Administered orally

Drug: Tadalafil
Administered orally

Experimental: LY2623091 (Group 4)
LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.
Drug: LY2623091
Administered orally

Experimental: Diltiazem + LY2623091 (Group 4)
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.
Drug: LY2623091
Administered orally

Drug: Diltiazem
Administered orally




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2623091 and Cytochrome (CYP) P450 Substrates [ Time Frame: Predose up to 20 days after drug administration in each period ]
  2. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY2623091 and Cytochrome (CYP) P450 Substrates [ Time Frame: Predose up to 20 days after drug administration in each period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300259


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02300259     History of Changes
Other Study ID Numbers: 15523
I7T-MC-RMAG ( Other Identifier: Eli Lilly and Company )
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Simvastatin
Itraconazole
Tadalafil
Hydroxyitraconazole
Diltiazem
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents