Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers
Phase 1
Completed
- Conditions
- Drug Pharmacokinetics in Healthy Volunteers
- Interventions
- Registration Number
- NCT03699774
- Lead Sponsor
- Daiichi Sankyo
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description All Participants Rosuvastatin 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. All Participants DS-8500a 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.
- Primary Outcome Measures
Name Time Method Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin on Day 1 of Period 1 and Day 14 of Period 2 Time of maximum observed concentration (Tmax) for single dose rosuvastatin 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 on Day 1 of Period 1 and Day 14 of Period 2
- Secondary Outcome Measures
Name Time Method Cmax for DS-8500a and its metabolites on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 Categories: DS-8500a, A209-3952, A210-2519, and A210-7951
Tmax for DS-8500a and its metabolites on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 Categories: DS-8500a, A209-3952, A210-2519, and A210-7951
AUC from time 0 to 24 hours (AUC0-24) for DS-8500a and its metabolites on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 Categories: DS-8500a, A209-3952, A210-2519, and A210-7951
Metabolite to parent (M:P) AUC0-24 ratios for DS-8500a and its metabolites on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 Categories: A209-3952:DS-8500a, A210-2519:DS-8500a, and A210-7951:DS-8500a
Cmax at steady state (Cmax,ss) Day 16 of Period 2 AUC during the 24 hour dosing interval (AUCtau) Day 16 of Period 2 Tmax at steady state (Tmax,ss) Day 16 of Period 2 Minimum observed analyte concentration that was just prior to the beginning of the dosing interval (Ctrough) Days 2, 3, 5, 7, 10, 14, and 16 of Period 2 Accumulation ratio (AccRatio) Day 16 of Period 2
Trial Locations
- Locations (1)
Worldwide Clinical Trials (WCT) Early Phase Services
🇺🇸San Antonio, Texas, United States