Drug Pharmacokinetics in Healthy Volunteers Clinical Trial
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.
| Verified date | October 2018 |
| Source | Daiichi Sankyo, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | July 6, 2015 |
| Est. primary completion date | July 6, 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Worldwide Clinical Trials (WCT) Early Phase Services | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Daiichi Sankyo, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin | on Day 1 of Period 1 and Day 14 of Period 2 | ||
| Primary | Time of maximum observed concentration (Tmax) for single dose rosuvastatin | on Day 1 of Period 1 and Day 14 of Period 2 | ||
| Primary | 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 | Cmax for DS-8500a and its metabolites | Categories: DS-8500a, A209-3952, A210-2519, and A210-7951 | on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 | |
| Secondary | Tmax for DS-8500a and its metabolites | Categories: DS-8500a, A209-3952, A210-2519, and A210-7951 | on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 | |
| Secondary | 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 | on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 | |
| Secondary | 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 | on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2 | |
| Secondary | 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 | ||
| Secondary | Cmax at steady state (Cmax,ss) | Day 16 of Period 2 | ||
| Secondary | AUC during the 24 hour dosing interval (AUCtau) | Day 16 of Period 2 | ||
| Secondary | Accumulation ratio (AccRatio) | Day 16 of Period 2 | ||
| Secondary | Tmax at steady state (Tmax,ss) | Day 16 of Period 2 |