Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Daiichi Sankyo24 enrolled

Overview

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 Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Drug Pharmacokinetics in Healthy Volunteers

Interventions

DS-8500aDRUG

DS-8500a is provided as three 25-mg tablets for oral administration

RosuvastatinDRUG

Rosuvastatin is provided as a 10-mg tablet for oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Worldwide Clinical Trials (WCT) Early Phase Services

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Cmax for DS-8500a and its metabolites

Categories: DS-8500a, A209-3952, A210-2519, and A210-7951

Time frame: 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

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

Categories: DS-8500a, A209-3952, A210-2519, and A210-7951

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

Categories: A209-3952:DS-8500a, A210-2519:DS-8500a, and A210-7951:DS-8500a

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)

Data from ClinicalTrials.gov

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