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Completed

NCT Number: NCT03699774

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

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.

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Key information

Conditions

Drug Pharmacokinetics in Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials (WCT) Early Phase Services

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DS-8500a

Drug

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

Other names: Experimental product

Rosuvastatin

Drug

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

Other names: Crestor

Primary outcomes

  1. Maximum observed plasma drug concentration (Cmax) for single dose rosuvastatin

    Time frame: on Day 1 of Period 1 and Day 14 of Period 2

  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

  3. 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

  1. Cmax for DS-8500a and its metabolites

    Time frame: 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

  2. Tmax for DS-8500a and its metabolites

    Time frame: 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

  3. AUC from time 0 to 24 hours (AUC0-24) for DS-8500a and its metabolites

    Time frame: 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

  4. Metabolite to parent (M:P) AUC0-24 ratios for DS-8500a and its metabolites

    Time frame: 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

  5. Minimum observed analyte concentration that was just prior to the beginning of the dosing interval (Ctrough)

    Time frame: Days 2, 3, 5, 7, 10, 14, and 16 of Period 2

  6. Cmax at steady state (Cmax,ss)

    Time frame: Day 16 of Period 2

  7. AUC during the 24 hour dosing interval (AUCtau)

    Time frame: Day 16 of Period 2

  8. Accumulation ratio (AccRatio)

    Time frame: Day 16 of Period 2

  9. Tmax at steady state (Tmax,ss)

    Time frame: Day 16 of Period 2

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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