Drug Pharmacokinetics in Healthy Volunteers
Conditions
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.
Interventions
DRUGDS-8500a
DS-8500a is provided as three 25-mg tablets for oral administration
DRUGRosuvastatin
Rosuvastatin is provided as a 10-mg tablet for oral administration
Sponsors
Daiichi Sankyo
Study design
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Fixed sequence
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| Cmax at steady state (Cmax,ss) | Day 16 of Period 2 | — |
| 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 |
| Accumulation ratio (AccRatio) | Day 16 of Period 2 | — |
| Tmax at steady state (Tmax,ss) | Day 16 of Period 2 | — |
| AUC during the 24 hour dosing interval (AUCtau) | Day 16 of Period 2 | — |
| 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 |
Countries
United States
Outcome results
None listed