Study of the Safety, Tolerability and Pharmacokinetics of LY2623091 after Single Oral Dosing in Healthy Subjects

The drug to be given is a new, investigational compound that may eventually be
used for the treatment of chronic kidney disease. This compound is in the
development phase. Chronic kidney disease is characterized by ongoing
deterioration of kidney function. Ultimately, total loss of kidney function may
occur, requiring patients to use dialysis or renal transplant to survive.
Current treatments do not counter the deterioration of kidney function
sufficiently. Consequently, new therapies are urgently needed for these
patients. The experimental drug used in this study is being developed to safely
improve kidney fuction in chronic kidney disease patients, using a novel
mechanism.

Primary objective:
- to investigate the safety and tolerability after a single oral dose in
healthy men and women of non-childbearing potential.

Secondary objective:
- to investigate the pharmacokinetic of a single oral dose in healthy men and
women of non-childbearing potential.

Design:
This study is a randomized, double-blind, placebo-controlled, dose escalating,
incomplete cross-over study. Two cohorts of 9 healthy men and women of
nonchildbearing potential are planned for inclusion in this study. The cohorts
will be dosed alternatively in the course of a dose escalation with the
proposed dose escalation scheme: 5 mg, 15 mg, 50 mg, 150 mg, 450 mg, and 900
mg. The 3-period dosing schedule will be separated by a washout period of at
least 7 days. A follow-up visit will take place 7-10 days after the last dose
for each subject.

Procedures and assessments:
Screening and follow-up: clinical laboratory (including aPTT at screening),
physical examination, 12-lead ECG (in triplicate at screening), vital signs
(including temperature and respiratory rate at screening); at eligibility
screening: medical history, drug screen, HBsAg, anti HCV, anti-HIV 1/2; to be
repeated upon admission: weight, abbreviated physical examination, urine
alcohol and drug screen.

Observation period:
Three periods in clinic from -17 h up to 72 h after drug administration on Day
1.

Blood sampling:
For pharmacokinetics in plasma: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48
and 72 hours post-dose and at follow-up visit
For pharmacogenomics: pre-dose on Day 1.

Safety assessments:
Adverse events: throughout the study; ECG (in triplicate) and vital signs:
pre-dose (including temperature and respiratory rate) and 1, 3, 6 and 24 h
post-dose; clinical laboratory: pre-dose (including aPTT) and 24 (including
aPTT) and 72 h post-dose.

Bioanalysis:
Analysis of plasma LY2623091 samples using a validated LC/MS method by Sponsor

Active substance: LY2623091

Procedures: pain, light bleeding, heamatoma, possibly an infection.