Effects of CS-8080 in Healthy Volunteers

Inclusion Criteria Healthy men and/or women, aged 18 to 45 years inclusive.

- Women must be of non-child bearing potential, ie, either:Surgically sterile (ie,
bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months
prior to dosing), or Naturally postmenopausal (spontaneous cessation of menses) for at
least 24 consecutive months prior to dosing, with an FSH level at screening of > 40
mIU/mL.

- All women must have a negative serum pregnancy test at screening and within 48 hours
before dosing.

- Body Mass Index (BMI) of 19 to 30 kg/m2 inclusive.

- Good health as determined by the absence of clinically significant deviation from
normal, based on medical history, physical examination, laboratory reports, and 12
lead ECG, as deemed by the Investigator, prior to enrollment.

- Able to understand and willing to comply with all study requirements, and willing to
follow the study medication regimen.

- Willing and able to give a written informed consent.

- Negative urine test for drugs of abuse and alcohol at screening and check-in.

- Negative result for HIV antibody, hepatitis B surface antigen, and hepatitis C
antibody at screening.

Exclusion Criteria

- Any history of drug abuse.

- History of alcohol addiction during the 2 years prior to Day 1.

- History of significant allergic response to any drug except penicillin.

- History or current evidence, as determined by the Investigator, of psychiatric or
emotional problems which would invalidate giving informed consent or limit the ability
of the subject to comply with study requirements.

- History or current evidence of clinically significant cardiac, hepatic, renal,
pulmonary, endocrine, neurologic, infectious, gastrointestinal (ie, any condition
which may affect drug absorption), hematologic, or oncologic disease as determined by
the Investigator after reviewing screening history, physical examination, laboratory
test results, and 12-lead ECG.

- History or current alcoholic or non-alcoholic liver disease or liver steatosis.

- History of prostate disease or prostatitis.

- Subjects with a history of congenital Long QT Syndrome (LQTS), a history of surviving
a near-drowning episode, or a history of any form of syncope or loss of consciousness.

- Subjects with QTc interval duration >450 msec obtained as an average from the ECG
machine readings on the triplicate ECG (3 readings in rapid succession and not more
than 2 minutes apart) taken at screening, after at least 10 minutes of quiet rest in a
supine position.

- Subjects with abnormal ECG waveform morphology on any of the ECGs from the screening
triplicate that would preclude accurate manual measurement of the QT interval
duration.

- Need for any concomitant medication.

- Prestudy medication use as specified in Section 6.2.1.

- Consumption of any food or beverages containing grapefruit from 7 days prior to Day 1
through study completion.

- Consumption of foods or beverages containing alcohol from 24 hours before check-in
through discharge from the clinic.

- Blood donation or significant blood loss within the 56 days before Day -1.

- Plasma donation within 7 days before Day -1.

- Participation in another investigational new drug research study within the 30 days
before Day 1.

- Use of tobacco products or nicotine-containing products (including smoking cessation
aids, such as gums or patches) within the 6 months before Day 1.

- Relationship of the subject to the Investigator, any sub-investigator, pharmacist,
study coordinator, or other staff directly involved in the conduct of the study, or
employment by the Sponsor or contract research organization participating in the
study.

- Screening laboratory values outside the range of normal values deemed clinically
significant by the Investigator. Serum lipid tests, triglycerides, cholesterol (LDL,
HDL and total cholesterol), liver function tests (ALT, AST, GGT, total bilirubin, LDH
and ALP) and PSA must not exceed the upper limit of normal without permission of the
Sponsor.

- Hemoglobin <12.0 g/dL at the screening visit.

- Shift work, defined as any work shifts, either regular or irregular, precluding sleep
during the hours of 10 pm and 6 am, within 1 week prior to Day -2, and no more than 2
works shifts per week meeting the above criteria from 4 to 1 week prior to Day -2.

- Positive fecal occult blood test at screening.

- Familial relationship with any other study participant.