A Study of LY2623091 in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300259
• Other study ID #: 15523
• Secondary ID: I7T-MC-RMAG
• Status: Completed
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2623091
Administered orally
• Itraconazole
Administered orally
• Simvastatin
Administered orally
• Tadalafil
Administered orally
• Diltiazem
Administered orally

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091		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
Primary	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091		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
Primary	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		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
Primary	Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid		Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose
Primary	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid		Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose
Primary	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		Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose