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A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02790671
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE May 31, 2016
First Posted Date  ICMJE June 6, 2016
Last Update Posted Date February 12, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
  • maximum concentration (Cmax) of DS-8500a [ Time Frame: Day 1 to Day 6 ]
    To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
  • time of maximum concentration (Tmax) of DS-8500a [ Time Frame: Day 1 to Day 6 ]
    To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
  • Area under the concentration curve (AUC) of DS-8500a [ Time Frame: Day 1 to Day 6 ]
    To assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02790671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
  • Number and severity of adverse events [ Time Frame: Day 1 to Day 31 ]
    To assess the the safety of DS-8500a
  • change in physical examination findings [ Time Frame: Day 1 to Day 31 ]
    To assess the the safety of DS-8500a
  • change in 12-lead electrocardiogram [ Time Frame: Day 1 to Day 31 ]
    To assess the the safety of DS-8500a
  • change in vital sign measurements [ Time Frame: Day 1 to Day 31 ]
    To assess the the safety of DS-8500a
  • change in clinical laboratory test results [ Time Frame: Day 1 to Day 31 ]
    To assess the the safety of DS-8500a
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy Subjects
Official Title  ICMJE An Open-Label, One-Sequence, Two-Period Study to Evaluate the Effects of Itraconazole on the Pharmacokinetics of DS-8500a in Healthy Subjects
Brief Summary Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: DS-8500a
    DS-8500a 25mg tablet
  • Drug: Itraconazole
    200mg itraconazole
Study Arms  ICMJE Experimental: single study arm
DS-8500a and itraconazole
Interventions:
  • Drug: DS-8500a
  • Drug: Itraconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2016)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects between 18 and 45 y of age, with a Body-Mass Index (BMI) of 18 kg/m2 to 30 kg/m2, inclusive, at Screening.
  • Good health as determined by evaluations performed at Screening and during Enrollment on Day -1.
  • Negative serum pregnancy test at Screening and a negative urine pregnancy test during Enrollment on Day -1 for all female subjects. Additionally, female subjects must be:

    • Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 mo prior to dosing)
    • Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive mo prior to dosing, with a follicle stimulating hormone (FSH) level at Screening of ≥ 40 mIU/mL
    • Non-lactating
  • Male subjects must agree to contraception (condom with spermicide) in addition to having their female partner (if of childbearing potential) use another form of contraception (eg, an intrauterine device, diaphragm with spermicide, oral contraceptive, injectables, or subdermal hormonal implant) from the first dose until 12 wk following last administration. Also, male subjects must not donate sperm during the study and afterwards for a period of 12 wk.
  • Provided written informed consent prior to participating in the study. Able to understand and willing to comply with all the study requirements, and willing to allow the collection of all blood and urine specimens.
  • Negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, phencyclidine), cotinine, and alcohol at Screening and During Enrollment on Day -1.
  • Willingness to abstain from grapefruit/grapefruit juice and Seville oranges 10 d before the first dose of study drug on Day 1 until the end of the study on Day 31.
  • Willingness to refrain from consuming food or beverages containing caffeine/xanthine and alcohol 24 h prior to Enrollment on Day -1 until the end of the study on Day 31.

Exclusion Criteria:

  • History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal (ie, any condition which may affect drug absorption), hematologic, or oncologic disease.
  • Laboratory results (serum chemistry, hematology, and urinalysis) outside of the normal range and considered clinically significant in the opinion of the PI. Liver function (AST, ALT, bilirubin) test results must be below the ULN at Screening and during Enrollment on Day -1.
  • A QTcF interval duration > 450 msec at Screening.
  • Participation in a previous DS-8500a study, or dosing with itraconazole, within 6 mo prior to the first dose.
  • Known sensitivity to product components of DS-8500a and/or itraconazole.
  • Current participation in another investigational study or prior participation in an investigational study within the past 30 d prior to the first dose.
  • Use of any prescription or over-the-counter (OTC) medications (systemic or topical), vitamins, or dietary/herbal supplements, including St John's Wort (hypericin), within 14 d prior to the first dose.
  • Consumption of more than 28 units of alcohol per wk (males) or 14 units of alcohol per wk (females), where 1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits, or significant history of alcoholism or drug/chemical abuse within the last 2 y.
  • Use of tobacco products or nicotine-containing products, including smoking cessation aids, such as gums or patches, within 6 mo prior to the first dose.
  • Positive test result for HBsAg, HCV, or HIV antibody.
  • Employment by the clinic.
  • Familial relationship (spouse and/or first degree relative) with another study participant.
  • Any other reason that, in the opinion of the PI, precludes subject participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02790671
Other Study ID Numbers  ICMJE DS8500-A-U109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP