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

NCT03699774 | Completed Phase 1 FDA Drug

• 1 other identifier: DS8500-A-U105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Pharmacokinetics in Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Cmax for DS-8500a and its metabolites

  on Day 1 (for single dose) and Day 16 (for multiple dose) 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

• 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

• 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

• 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

Study Arms (1)

All Participants

EXPERIMENTAL

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.

Drug: DS-8500a; Drug: Rosuvastatin

Interventions

DS-8500a DRUG

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

Also known as: Experimental product

All Participants

Rosuvastatin DRUG

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

Also known as: Crestor

All Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Worldwide Clinical Trials (WCT) Early Phase Services

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

• 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.

  PMID: 31321631 DERIVED

MeSH Terms

Interventions

firuglipel; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fixed sequence

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: May 12, 2015
• Primary Completion: July 6, 2015
• Study Completion: July 6, 2015
• Last Updated: February 12, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (1)