Drug Pharmacokinetics in Healthy VolunteersPhase 1NCT03699774
Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers
A Phase 1 study testing DS-8500a and Rosuvastatin in people with Drug Pharmacokinetics in Healthy Volunteers, run by Daiichi Sankyo at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin. The total length of time (from screening to follow-up) for each participant is approximately 7 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Pharmacokinetics in Healthy Volunteers
- What is being tested?
- DS-8500a and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2015to 6 Jul 2015
- 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
- Is healthy and of non-child-bearing potential
- Has a body mass index of 18-30 kg/m^2
- Has negative results for drugs of abuse, cotinine (smoking) and alcohol at screening
- Has signed informed consent and agreed to comply with all study requirements
Who cannot join
- Has history or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal , hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results, or 12-lead ECG
- Has any other condition detailed in the protocol, or that in the opinion of the Investigator, precludes participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials (WCT) Early Phase Services
San Antonio, Texas, 78217
About this study
Official title: An Open-label, Fixed Sequence, Two-period Study to Evaluate the Effects of Repeated Doses of DS-8500a on the Pharmacokinetics of Rosuvastatin in Healthy Subjects.
The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin.
The total length of time (from screening to follow-up) for each participant is approximately 7 weeks.
It is expected that repeated oral doses of DS-8500a will not have a significant effect on the pharmacokinetics of a single dose of rosuvastatin.
- Being tested
- DS-8500a, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-8500aDrug
Also called Experimental product
DS-8500a is provided as three 25-mg tablets for oral administration
RosuvastatinDrug
Also called Crestor
Rosuvastatin is provided as a 10-mg tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | In treatment Period 1 (Day 1 through Day 4), on Day 1, participants receive a single dose of rosuvastatin 10 mg orally with food, and in Period 2 (Day 1 through Day 16), starting on Day 1, participants receive DS-8500a 75 mg orally qd with food for 16 days with concomitant administration of a single dose of rosuvastatin 10 mg qd on Day 14.
In both the periods, rosuvastatin and DS-8500a are administered after an overnight fast of 8 hours and within 10 minutes after consuming a standardized breakfast of 500 calories. Receives: Drug: DS-8500a; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin
Measured: on Day 1 of Period 1 and Day 14 of Period 2
Time of maximum observed concentration (Tmax) for single dose rosuvastatin
Measured: on Day 1 of Period 1 and Day 14 of Period 2
Area under the plasma concentration time curve (AUC) from time 0 to the last quantifiable concentration (AUClast) for single dose rosuvastatin
Measured: on Day 1 of Period 1 and Day 14 of Period 2
Secondary outcomes (9)
Cmax for DS-8500a and its metabolites
Categories: DS-8500a, A209-3952, A210-2519, and A210-7951
Measured: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
Tmax for DS-8500a and its metabolites
Categories: DS-8500a, A209-3952, A210-2519, and A210-7951
Measured: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
AUC from time 0 to 24 hours (AUC0-24) for DS-8500a and its metabolites
Categories: DS-8500a, A209-3952, A210-2519, and A210-7951
Measured: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
Metabolite to parent (M:P) AUC0-24 ratios for DS-8500a and its metabolites
Categories: A209-3952:DS-8500a, A210-2519:DS-8500a, and A210-7951:DS-8500a
Measured: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
Minimum observed analyte concentration that was just prior to the beginning of the dosing interval (Ctrough)
Measured: Days 2, 3, 5, 7, 10, 14, and 16 of Period 2
Cmax at steady state (Cmax,ss)
Measured: Day 16 of Period 2
AUC during the 24 hour dosing interval (AUCtau)
Measured: Day 16 of Period 2
Accumulation ratio (AccRatio)
Measured: Day 16 of Period 2
Tmax at steady state (Tmax,ss)
Measured: Day 16 of Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start12 May 2015
- Primary completion6 Jul 2015
- Study completion6 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Pharmacokinetics in Healthy VolunteersStudies 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
- Basic science
- Intervention model
- Sequential
- Model description
- Fixed sequence
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699774
- Sponsor's protocol ID
- DS8500-A-U105
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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/
Publications
Maekawa Y, Furuie H, Kato M, Myobatake Y, Kamiyama E, Watanabe A, Shiosakai K, Taguchi T, Bass R, Zhou J, Dishy V, Warren V, Vashi V, Ishizuka H. Effect of DS-8500a, a Novel G Protein-Coupled Receptor 119 Agonist, on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects. Clin Drug Investig. 2019 Oct;39(10):967-978. doi: 10.1007/s40261-019-00825-1.
PubMed 31321631
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
- An Open-label, Fixed Sequence, Two-period Study to Evaluate the Effects of Repeated Doses of DS-8500a on the Pharmacokinetics of Rosuvastatin in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03699774
- Acronym / sponsor ID
- DS8500-A-U105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 12 May 2015 (actual)
- Primary completion
- 6 Jul 2015 (actual)
- Study completion
- 6 Jul 2015 (actual)
- First posted
- 9 Oct 2018 (actual)
- 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 primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin.
The total length of time (from screening to follow-up) for each participant is approximately 7 weeks.
It is expected that repeated oral doses of DS-8500a will not have a significant effect on the pharmacokinetics of a single dose of rosuvastatin.
Study design
- Primary purpose
- Basic science
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed sequence
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: DS-8500a, Drug: RosuvastatinIn treatment Period 1 (Day 1 through Day 4), on Day 1, participants receive a single dose of rosuvastatin 10 mg orally with food, and in Period 2 (Day 1 through Day 16), starting on Day 1, participants receive DS-8500a 75 mg orally qd with food for 16 days with concomitant administration of a single dose of rosuvastatin 10 mg qd on Day 14. In both the periods, rosuvastatin and DS-8500a are administered after an overnight fast of 8 hours and within 10 minutes after consuming a standardized breakfast of 500 calories. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is healthy and of non-child-bearing potential
- Has a body mass index of 18-30 kg/m^2
- Has negative results for drugs of abuse, cotinine (smoking) and alcohol at screening
- Has signed informed consent and agreed to comply with all study requirements
Key exclusion criteria (2 listed)
- Has history or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal , hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results, or 12-lead ECG
- Has any other condition detailed in the protocol, or that in the opinion of the Investigator, precludes participation in the study
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-8500aAlso: Experimental productDS-8500a is provided as three 25-mg tablets for oral administration | Drug | All Participants |
| RosuvastatinAlso: CrestorRosuvastatin is provided as a 10-mg tablet for oral administration | Drug | All Participants |
Primary outcome
Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin
Time frame: on Day 1 of Period 1 and Day 14 of Period 2
Time of maximum observed concentration (Tmax) for single dose rosuvastatin
Time frame: on Day 1 of Period 1 and Day 14 of Period 2
Area under the plasma concentration time curve (AUC) from time 0 to the last quantifiable concentration (AUClast) for single dose rosuvastatin
Time frame: on Day 1 of Period 1 and Day 14 of Period 2
9 secondary outcomes
Cmax for DS-8500a and its metabolites
Time frame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
Tmax for DS-8500a and its metabolites
Time frame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
AUC from time 0 to 24 hours (AUC0-24) for DS-8500a and its metabolites
Time frame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
Metabolite to parent (M:P) AUC0-24 ratios for DS-8500a and its metabolites
Time frame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
Minimum observed analyte concentration that was just prior to the beginning of the dosing interval (Ctrough)
Time frame: Days 2, 3, 5, 7, 10, 14, and 16 of Period 2
Cmax at steady state (Cmax,ss)
Time frame: Day 16 of Period 2
AUC during the 24 hour dosing interval (AUCtau)
Time frame: Day 16 of Period 2
Accumulation ratio (AccRatio)
Time frame: Day 16 of Period 2
Tmax at steady state (Tmax,ss)
Time frame: Day 16 of Period 2
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.
- Derived from this study: PubMed 31321631Maekawa Y, Furuie H, Kato M, Myobatake Y, Kamiyama E, Watanabe A, Shiosakai K, Taguchi T, Bass R, Zhou J, Dishy V, Warren V, Vashi V, Ishizuka H. Effect of DS-8500a, a Novel G Protein-Coupled Receptor 119 Agonist, on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects. Clin Drug Investig. 2019 Oct;39(10):967-978. doi: 10.1007/s40261-019-00825-1.
- 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/
Related trials for Drug Pharmacokinetics in Healthy Volunteers
RecruitingPhase 1
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Healthy
Not yet recruitingPhase 1
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
PK Drug-drug Interaction Study
RecruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
Healthy Volunteer Study, Healthy Adults
Not yet recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults
Alzheimer Disease
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
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.
Clinical Study Leader study director
Daiichi Sankyo
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 and Rosuvastatin in people with Drug Pharmacokinetics in Healthy Volunteers, 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 4 inclusion and 2 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?
Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin (time frame: on Day 1 of Period 1 and Day 14 of Period 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699774, which also lists 1 linked publication.
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.