Clinical trial NCT03699774: Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Pharmacokinetics in Healthy Volunteers
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Intervention model description: Fixed sequence
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin
timeFrame: on Day 1 of Period 1 and Day 14 of Period 2
measure: Time of maximum observed concentration (Tmax) for single dose rosuvastatin
timeFrame: on Day 1 of Period 1 and Day 14 of Period 2
measure: Area under the plasma concentration time curve (AUC) from time 0 to the last quantifiable concentration (AUClast) for single dose rosuvastatin
timeFrame: on Day 1 of Period 1 and Day 14 of Period 2
Secondary outcomes:
measure: Cmax for DS-8500a and its metabolites
timeFrame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
measure: Tmax for DS-8500a and its metabolites
timeFrame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
measure: AUC from time 0 to 24 hours (AUC0-24) for DS-8500a and its metabolites
timeFrame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
measure: Metabolite to parent (M:P) AUC0-24 ratios for DS-8500a and its metabolites
timeFrame: on Day 1 (for single dose) and Day 16 (for multiple dose) of Period 2
measure: Minimum observed analyte concentration that was just prior to the beginning of the dosing interval (Ctrough)
timeFrame: Days 2, 3, 5, 7, 10, 14, and 16 of Period 2
measure: Cmax at steady state (Cmax,ss)
timeFrame: Day 16 of Period 2
measure: AUC during the 24 hour dosing interval (AUCtau)
timeFrame: Day 16 of Period 2
measure: Accumulation ratio (AccRatio)
timeFrame: Day 16 of Period 2
measure: Tmax at steady state (Tmax,ss)
timeFrame: Day 16 of Period 2
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials (WCT) Early Phase Services
state: Texas
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
citation: 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.