Effects of Multiple Doses of CS-8080 in Healthy Volunteers

NCT00796575 | Terminated Phase 1

• 1 other identifier: CS8080-A-U102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

multiple ascending dose healthy volunteers; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (4)

• Safety

  21 days

• plasma pharmacokinetics after multiple doses

  16 days

• effect on ABCA1 mRNA after multiple doses

  16 days

• effect on ABCG1 mRNA after multiple doses

  16 days

Secondary Outcomes (6)

• 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

Study Arms (2)

CS-8080

EXPERIMENTAL

3 mg CS-8080, 10mg CS-8080, 20 mg CS-8080

Drug: CS-8080

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo tablets

Interventions

CS-8080 DRUG

CS-8080 1mg tablets, 3 tablets administered 1 times per day

CS-8080

placebo tablets DRUG

placebo tablets matching active

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subjects must agree not to donate blood, plasma, platelets, or any other blood components during the study and for 4 weeks after the last dose.

You may not qualify if:

• 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 1.
• 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.
• Subjects with QTcF interval duration \>450 msec obtained as an average from the ECG machine readings on the triplicate ECG (3 readings 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 protocol.
• Consumption of any food or beverages containing grapefruit from 7 days prior to Day 1 through study completion.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

MDS Pharma Services

Neptune City, New Jersey, 07753, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 21, 2018

Record last verified: 2015-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (1)