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Completed

NCT Number: NCT02300259

A Study of LY2623091 in Healthy Participants

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2623091

Drug

Administered orally

Itraconazole

Drug

Administered orally

simvastatin

Drug

Administered orally

Tadalafil

Drug

Administered orally

Diltiazem

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091

    Time frame: Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose

  2. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091

    Time frame: Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose

  3. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091

    Time frame: Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose

  4. Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid

    Time frame: Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose

  5. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid

    Time frame: Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose

  6. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid

    Time frame: Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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