Effects of CS-8080 in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The main purposes of this study are to assess the safety and measure the pharmacokinetics of CS-8080 in healthy volunteers.

Key facts

Study ID

NCT00613431

Run by

Daiichi Sankyo

People needed

72

Starts

2008-01-01

Last updated by the study team

2018-12-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.

Where it is running

• MDS Pharma Services — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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