Phase 1
Completed N=48
A Study of LY2623091 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02300259 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091 — 61.9; 66.9; 61.8; 64.2 nanograms per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091 |
61.9; 66.9; 61.8; 64.2 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091 |
2540; 5660; 2390; 3360 | — |
| 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 |
2480; 5240; 2340; 3130 | — |
| PRIMARY Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid |
7.78; 9.89; 0.720; 0.877 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid |
17.4; 24.1; 7.15; 8.88 | — |
| 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 |
16.5; 23.0; 5.42; 6.87 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02300259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.