Clinical trial NCT00613431: Effects of CS-8080 in Healthy Volunteers
Official title: A Randomized, Placebo-Controlled, Single Ascending Dose Study To Assess The Safety, Tolerability and Pharmacokinetics Of CS-8080 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacodynamics
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Safety assessed over the 5-day post-dose inpatient period and at a follow-up 1 week post-discharge.
timeFrame: 2 weeks
measure: Single dose plasma pharmacokinetics of CS-8080
timeFrame: 2 weeks
Secondary outcomes:
measure: Pharmacodynamic response to CS-8080, as assessed by mRNA levels to 24 h post-dose.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Neptune
country: United States
facility: MDS Pharma Services
state: New Jersey
Study officials:
affiliation: MDS Pharma Services
name: Robert Noveck, MD
role: PRINCIPAL_INVESTIGATOR
References: