NCT00796575
Terminated
Phase 1
A Randomized, Placebo-Controlled, Multiple Ascending Dose Study To Assess The Safety, Pharmacokinetics and Pharmacodynamics Of CS-8080 In Healthy Volunteers
Overview
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Daiichi Sankyo
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- effect on ABCA1 mRNA after multiple doses
Overview
Brief Summary
The main purposes of this study are to assess the safety and measure the pharmacokinetics and pharmacodynamics of CS-8080 in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy men and/or women, aged 18 to 45 years inclusive.
- •WOCBP cannot be pregnant or nursing, must have been using a medically acceptable method of contraception for at least 3 months prior to study screening
- •All women must have a negative quantitative serum pregnancy test at screening, on Day -4, and within 24 hours before dosing.
- •Male subjects must agree not to donate sperm during the study and for 3 months after their last scheduled visit. Males must also agree to use a use a condom with spermicide whenever engaging in sexual activity for this period of time.
- •Body Mass Index (BMI) of 19 to 30 kg/m inclusive and weight \<300 lbs.
- •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
- •WOCBP is pregnant (as based on test results) or is breast feeding.
- •Subject is not using adequate contraceptive precautions.
- •Any history of drug abuse.
- •History of alcohol addiction during the 2 years prior to Day
- •History of significant allergic response to any drug except penicillin, or known sensitivity to any of the products to be administered during dosing.
- •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.
Arms & Interventions
CS-8080
Experimental
3 mg CS-8080, 10mg CS-8080, 20 mg CS-8080
Intervention: CS-8080 (Drug)
placebo
Placebo Comparator
placebo
Intervention: placebo tablets (Drug)
Outcomes
Primary Outcomes
effect on ABCA1 mRNA after multiple doses
Time Frame: 16 days
effect on ABCG1 mRNA after multiple doses
Time Frame: 16 days
Safety
Time Frame: 21 days
plasma pharmacokinetics after multiple doses
Time Frame: 16 days
Secondary Outcomes
- effect on gene expression by microarray after multiple doses(16 days)
- effect on triglycerides following an oral fat load after multiple doses(16 days)
- effect on plasma lipids after multiple doses(16 days)
- effect on lipoproteins after multiple doses(16 days)
- effect on HDL particle distribution after multiple doses(16 days)
- effect on hepatic fat content after multiple doses(16 days)
Investigators
Study Sites (1)
Loading locations...
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