HealthyPhase 1NCT00796575
Effects of Multiple Doses of CS-8080 in Healthy Volunteers
A Phase 1 study testing CS-8080 in people with Healthy, run by Daiichi Sankyo at 1 site in United States.
Trial summary
The main purposes of this study are to assess the safety and measure the pharmacokinetics and pharmacodynamics of CS-8080 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CS-8080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Prior exposure to CS-8080.
- 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.
- Familial relationship with any other study participant.
- 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. For males, testosterone, LH and FSH must be within normal limits.
- Hemoglobin <12.0 g/dL at the screening visit.
- Positive fecal occult blood test at screening.
- 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 -4, and no more than 2 works shifts per week meeting the above criteria from 4 to 1 week prior to Day -4.
- Any of the following, if determined to render the subject ineligible for hepatic MRI scanning: pacemaker, aneurism clips, heart valve replacements, cochlear implants, neuro- or spine-stimulator, pessary (bladder support), body piercing that cannot be removed, metal slivers in eyes, shrapnel, hearing aid that cannot be removed, non-removable metal dental work or dentures, tattoos over 20 years old, IUD or penile implant. An X-ray may be required to assess eligibilty for the procedure.
- History of claustrophobia or intolerance to MRI scanning procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Multiple Ascending Dose Study To Assess The Safety, Pharmacokinetics and Pharmacodynamics Of CS-8080 In Healthy Volunteers
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
- Being tested
- CS-8080, placebo tablets
- Keywords
- multiple ascending dose healthy volunteers, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-8080Drug
CS-8080 1mg tablets, 3 tablets administered 1 times per day
placebo tabletsDrug
placebo tablets matching active
CS-8080Drug
CS-8080 5 mg tablets, 2 tablets administered 1 times per day
CS-8080Drug
CS-8080 5 mg tablets, 4 tablets administered 1 times per day
| Study group | Role | What they receive |
|---|---|---|
| CS-8080 | Experimental | 3 mg CS-8080, 10mg CS-8080, 20 mg CS-8080 Receives: Drug: CS-8080 |
| placebo | Placebo comparator | placebo Receives: Drug: placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 21 days
plasma pharmacokinetics after multiple doses
Measured: 16 days
effect on ABCA1 mRNA after multiple doses
Measured: 16 days
effect on ABCG1 mRNA after multiple doses
Measured: 16 days
Secondary outcomes (6)
effect on gene expression by microarray after multiple doses
Measured: 16 days
effect on triglycerides following an oral fat load after multiple doses
Measured: 16 days
effect on plasma lipids after multiple doses
Measured: 16 days
effect on lipoproteins after multiple doses
Measured: 16 days
effect on HDL particle distribution after multiple doses
Measured: 16 days
effect on hepatic fat content after multiple doses
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796575
- Sponsor's protocol ID
- CS8080-A-U102
- Status last verified
- Apr 2015
- First submitted
- 21 Nov 2008
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Multiple Ascending Dose Study To Assess The Safety, Pharmacokinetics and Pharmacodynamics Of CS-8080 In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00796575
- Acronym / sponsor ID
- CS8080-A-U102
- Conditions
- Healthy
- Keywords
- multiple ascending dose healthy volunteers, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS-8080 | Experimental | Drug: CS-80803 mg CS-8080, 10mg CS-8080, 20 mg CS-8080 |
| placebo | Placebo comparator | Drug: placebo tabletsplacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS-8080CS-8080 1mg tablets, 3 tablets administered 1 times per day | Drug | CS-8080 |
| placebo tabletsplacebo tablets matching active | Drug | placebo |
| CS-8080CS-8080 5 mg tablets, 2 tablets administered 1 times per day | Drug | CS-8080 |
| CS-8080CS-8080 5 mg tablets, 4 tablets administered 1 times per day | Drug | CS-8080 |
Primary outcome
Safety
Time frame: 21 days
plasma pharmacokinetics after multiple doses
Time frame: 16 days
effect on ABCA1 mRNA after multiple doses
Time frame: 16 days
effect on ABCG1 mRNA after multiple doses
Time frame: 16 days
6 secondary outcomes
effect on gene expression by microarray after multiple doses
Time frame: 16 days
effect on triglycerides following an oral fat load after multiple doses
Time frame: 16 days
effect on plasma lipids after multiple doses
Time frame: 16 days
effect on lipoproteins after multiple doses
Time frame: 16 days
effect on HDL particle distribution after multiple doses
Time frame: 16 days
effect on hepatic fat content after multiple doses
Time frame: 16 days
Results and safety
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS-8080 in people with Healthy, run by Daiichi Sankyo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.