Phase 1
Completed N=24
A Study of LY2835219 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02256267 ↗
Enrolled (actual)
24
Serious AEs
1.4%
Results posted
Aug 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219 — 134; 10.5 nanogram per milliliter (ng/ml)
Summary
The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.
The study will last about 34 days. Screening is required within 28 days before study drug is given.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219 |
134; 10.5 | — |
| PRIMARY PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219 |
4570; 229 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy sterile males or surgically sterile females or postmenopausal females
- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)
Exclusion Criteria
- Have participated in a clinical trial involving investigational product within the last 30 days
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure
- Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study
Data sourced from ClinicalTrials.gov (NCT02256267). 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.