Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
Loxo Oncology, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Participants with impaired renal function \[estimated Glomerular Filtration Rate (eGFR): \< 90 milliliters per minute (mL/min) per 1.73 square meters (m2)\] and healthy participants with normal renal function \[(eGFR: ≥ 90 mL/min/1.73 m2)\].
Males and females of non-childbearing potential.
Within body mass index (BMI) range 18.5 to 40.0 kilograms per square meter (kg/m²).
Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
Able to comply with all study procedures, including the 8-night stay at the Clinical Research Unit and follow-up phone call.
You may not be if
History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
1. liver disease
2. pancreatitis
3. peptic ulcer disease
4. intestinal malabsorption
5. gastric reduction surgery
6. history or presence of clinically significant cardiovascular disease.
Participants with out-of-range, at-rest vital signs.
Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
Receipt of blood products within 2 months prior to Check-in (Day -1).
Significant history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
