The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers
The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers
This study will test if a study drug (CS-3150) will affect the heart rate in healthy males
 and females. Two doses of the study drug will be tested. Heart rate is not expected to be
 different between the study groups.
This study will assess the effect of therapeutic and supratherapeutic plasma exposures of
 CS-3150 on the corrected QT (QTc) interval duration after administration of single oral 10-mg
 and 40-mg doses of CS-3150 in healthy male and female participants. This study will also
 determine the safety and tolerability of CS-3150 administration, assess the effect on
 electrocardiogram (ECG) parameters, detect QT interval (QT)/QTc prolongation with a positive
 control (moxifloxacin), characterize pharmacokinetics (PK) of CS-3150, and assess
 exposure-response relationship of CS-3150 on QTc.
Inclusion Criteria:

 -  Healthy males and/or females 18 years to 45 years of age with a body mass index of 19
 kg/m2 to 32 kg/m2 (inclusive)

 -  Laboratory results (serum chemistry, hematology, and urinalysis [UA]), liver function,
 and serum K+ levels within normal range

 -  Written informed consent

 -  Female participants: Negative pregnancy test and must either be surgically sterile,
 postmenopausal, or agree to use acceptable nonhormonal contraception.

 Exclusion Criteria:

 -  All prescription or over-the-counter (OTC) medication (systemic and topical) and
 herbal supplements will not be permitted for 14 days before the first dose and for the
 duration of the study.

 -  Oral, injected, or implanted hormonal contraception methods, or hormonal replacement
 therapy, should not have been received in the 3 months prior to the first dose, and
 for the duration of the study.

 -  Female participants: positive pregnancy test or are breast feeding.

 -  Supine systolic/diastolic blood pressure at screening, after resting for 10 min,
 higher than 140/90 mmHg or lower than 90/50 mmHg, confirmed after repeated testing at
 least approximately 1 h apart.

 -  Supine pulse at screening, after resting for 10 min, outside the range of 40 to 100
 beats per minute (bpm).

 -  QTcF interval duration > 450 ms for male and female obtained as an average from the
 triplicate screening ECGs after at least 10 min in a fully supine quiet rest.

 -  Abnormal waveform morphology on any of the screening ECGs that would preclude accurate
 measurement of the QT interval duration.

 -  Family history of congenital Long QT syndrome (LQTS), a history of surviving an
 unexplained drowning episode, a history of any form of syncope or loss of
 consciousness, or known symptomatic cardiac arrhythmias.

 -  Known allergy to moxifloxacin.

 -  An estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal
 Disease (MDRD) equation lower than 90 mL/min.

 -  Previous participation in a CS-3150 study within 6 months prior to the single dose of
 CS-3150.

 -  History or current evidence of clinically significant cardiac, hepatic, renal,
 pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, or
 oncologic disease as determined by the PI after reviewing screening history, physical
 examination, laboratory test results, and 12-lead ECG

 -  Clinically significant illness (at the discretion of principal investigator) within 4
 weeks of first dose, are carriers of Hepatitis B surface antigen (HBsAg), Hepatitis C
 antibody (HCV), or human immunodeficiency virus (HIV) antibody, and any other reason
 not deemed suitable for the study (at the discretion of the principal investigator).