PharmacokineticsPhase 1NCT02790684
A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects
A Phase 1 study testing DS-8500a in people with Pharmacokinetics, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- DS-8500a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 2016
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 years (y) and 60 y of age, inclusive.
- Subjects must have a body mass index (BMI) of 19 kg/m2 to 30 kg/m2, inclusive; or, if outside the range, not clinically significant and agreed with Sponsor and primary investigator (PI).
- Subjects must be in good health as determined at Screening and Day -1 (Check-in) assessed by medical history (Screening only), physical examination, vital signs, hematology, virology (Screening only), and urinalysis.
- Laboratory results (serum chemistry, hematology, and urinalysis) must not be outside the normal range or if outside the normal range, then the PI considers the value not clinically relevant.
- Subjects must agree not to participate in any other investigational study until the end of the trial.
- Subjects must be willing to abstain from grapefruit/grapefruit juice and Seville oranges from 10 d before the first dose of study medication and throughout the study.
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- Subjects must be willing to refrain from consuming food or beverages containing caffeine/xanthine and alcohol starting 24 h prior to Check-in on Day -1.
- Subjects must be able to understand and willing to comply with all study requirements, and willing to allow the collection of all blood, fecal, and urine specimens.
- Subjects must give written informed consent to participate in the study prior to Screening. Consent will be documented by the subject's dated signature that will be counter signed and dated by a witness. The appropriate HIPAA authorization forms must be signed and dated by the subject.
- Male subjects must agree to contraception (condom with spermicide) in addition to having their female partner (if of childbearing potential) use another form of contraception (eg, an intrauterine device, diaphragm with spermicide, oral contraceptive, injectables, or subdermal hormonal implant) from the first dose until 12 wk following the last dose administration. Also, male subjects must not donate sperm for a period of 12 wk following drug administration.
- Subject must have a history of regular bowel movements (defined in this instance as a bowel movement at least every other d without the need for medication).
- Subjects must be willing to eat entire meals and snacks provided during the stay at the research facility and understand that the diet will include foods with high fiber content and possibly prune juice.
Who cannot join
- Subjects who have received any prescription or non-prescription (over-the-counter [OTC]) systemic medication, topical medication, or herbal supplement (including St. John's Wort [hypericin]) within 14 d prior to dosing.
- Subjects who participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within 30 d or 5 half-lives of that investigational drug or marketed drug prior to dosing.
- Subjects who were administered radiolabeled substances or exposed to significant radiation (eg, serial X-rays or computed tomography (CT) scans, barium meal, occupational exposure etc) within 12-mo of dosing.
- Subjects who have been involved in an occupation that requires monitoring for radiation exposure (eg, X-ray technician).
- Liver function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin [TBL]) test results range should not be be > upper limit of normal at Screening and during Enrollment on Day -1.
- Subjects with an estimated glomerular filtration rate (eGFR) (using Modification of Diet in Renal Disease [MDRD] equation) < 90 mL/min.
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- Subjects with Fridericia's corrected QT interval (QTcF) interval duration > 450 ms, obtained as an average from the 3 ECG recorder's measurements on triplicate Screening ECGs (3 ECGs in close succession at least 1 min apart) taken after at least 10 min of quiet rest in the supine position.
- Subjects with abnormal waveform morphology on any of the ECGs at the Screening and on Day -1 that would preclude accurate measurement of the time for both ventricular depolarization and repolarization (QT) interval duration.
- Subject who have participated in a previous DS-8500a study within 6-mo prior to the screening.
- Subjects with a history of significant allergic response to any drug except penicillin.
- Subjects with a history of any serious disorder, including cardiovascular, hematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 y), neurologic, and psychiatric diseases, or any disorder that may prevent the successful completion of the study.
- Subjects who consume more than 28 units of alcohol per wk (one unit of alcohol equals one-half pint of beer, 4 oz of wine, or 1 oz of spirits) or those subjects who have a significant history of alcoholism or drug/chemical abuse within 2 y prior to Screening.
- Subjects who have used tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within 6-mo prior to dosing.
- Subjects with positive results on tests for drugs of abuse, cotinine, or alcohol at Screening and on Day -1.
- Subjects who test positive for HBsAg, or antibody to HCV or HIV, at Screening.
- Subject is employed by the clinic.
- Subjects who have a familial relationship with another study participant.
- Subjects who, in the opinion of the PI, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive. The radiolabeled investigational medicinal product will be administered to 12 healthy male subjects in 2 cohorts of 6 subjects each.
- Conditions
- Pharmacokinetics
- Being tested
- DS-8500a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-8500aDrug
| Study group | Role | What they receive |
|---|---|---|
| DS-8500a | Experimental | Not described Receives: Drug: DS-8500a |
What is being measured
The primary outcome is the main question the study is designed to answer.
total 14C radioactivity in urine and feces
to determine mass balance (excretion) of DS-8500a
Measured: Day 1 to Day 21
Secondary outcomes (4)
Maximum concentration (Cmax) of DS-8500a
determine the pharmacokinetics of DS-8500a
Measured: Day 1 to Day 21
Time of maximum concentration (Tmax) of DS-8500a
determine the pharmacokinetics of DS-8500a
Measured: Day 1 to Day 21
Area under the concentration curve (AUC) of DS-8500a
determine the pharmacokinetics of DS-8500a
Measured: Day 1 to Day 21
number and severity of adverse events
to determine the safety and tolerability of DS-8500a
Measured: Day 1 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02790684
- Sponsor's protocol ID
- DS8500-A-U112
- Status last verified
- Sep 2017
- First submitted
- 1 Jun 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02790684
- Acronym / sponsor ID
- DS8500-A-U112
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jun 2016 (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.
This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive. The radiolabeled investigational medicinal product will be administered to 12 healthy male subjects in 2 cohorts of 6 subjects each.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS-8500a | Experimental | Drug: DS-8500a |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male subjects between 18 years (y) and 60 y of age, inclusive.
- Subjects must have a body mass index (BMI) of 19 kg/m2 to 30 kg/m2, inclusive; or, if outside the range, not clinically significant and agreed with Sponsor and primary investigator (PI).
- Subjects must be in good health as determined at Screening and Day -1 (Check-in) assessed by medical history (Screening only), physical examination, vital signs, hematology, virology (Screening only), and urinalysis.
- Laboratory results (serum chemistry, hematology, and urinalysis) must not be outside the normal range or if outside the normal range, then the PI considers the value not clinically relevant.
- Subjects must agree not to participate in any other investigational study until the end of the trial.
Key exclusion criteria (18 listed)
- Subjects who have received any prescription or non-prescription (over-the-counter [OTC]) systemic medication, topical medication, or herbal supplement (including St. John's Wort [hypericin]) within 14 d prior to dosing.
- Subjects who participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within 30 d or 5 half-lives of that investigational drug or marketed drug prior to dosing.
- Subjects who were administered radiolabeled substances or exposed to significant radiation (eg, serial X-rays or computed tomography (CT) scans, barium meal, occupational exposure etc) within 12-mo of dosing.
- Subjects who have been involved in an occupation that requires monitoring for radiation exposure (eg, X-ray technician).
- Liver function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin [TBL]) test results range should not be be > upper limit of normal at Screening and during Enrollment on Day -1.
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 |
|---|---|---|
| DS-8500a | Drug | DS-8500a |
Primary outcome
total 14C radioactivity in urine and feces
Time frame: Day 1 to Day 21
to determine mass balance (excretion) of DS-8500a
4 secondary outcomes
Maximum concentration (Cmax) of DS-8500a
Time frame: Day 1 to Day 21
Time of maximum concentration (Tmax) of DS-8500a
Time frame: Day 1 to Day 21
Area under the concentration curve (AUC) of DS-8500a
Time frame: Day 1 to Day 21
number and severity of adverse events
Time frame: Day 1 to Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- 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 DS-8500a in people with Pharmacokinetics, 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 12 inclusion and 18 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: finished, as of the sponsor's last update on 12 Feb 2019. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
total 14C radioactivity in urine and feces (time frame: Day 1 to Day 21). 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 12 Feb 2019.