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Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.

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ClinicalTrials.gov Identifier: NCT02107885
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by healthy male subjects.

Condition or disease Intervention/treatment Phase
Safety Tolerability Pharmacokinetics Drug: DS-1971 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1, Double-blind, Randomized, Placebo-controlled Single Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male Subjects
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: DS-1971
single ascending dose of 5mg, 10mg, 30mg, 90mg, 250mg, 500mg, 1000mg, 1500mg.
Drug: DS-1971
6 subjects in each group will receive DS-1971.

Placebo Comparator: placebo
placebo matching each of the DS-1971 dosages.
Drug: placebo
2 subjects in each group will receive placebo.




Primary Outcome Measures :
  1. safety and tolerability adverse events [ Time Frame: 20 days after dose ]
    determine number, type, and severity of adverse events

  2. safety and tolerability physical exam [ Time Frame: 20 days after dose ]
    determine adverse changes in vital signs, ECG.

  3. safety and tolerability laboratory blood and urine tests [ Time Frame: from day 1 through 20 days after dose ]
    determine adverse changes in laboratory safety tests of blood (biochemistry and haematology) and urine.


Secondary Outcome Measures :
  1. plasma concentration AUC [ Time Frame: day 4 ]
    concentration in blood measured as Area under the curve (AUC)

  2. maximum blood concentration [ Time Frame: day 4 ]
    Cmax

  3. time of maximum blood concentration [ Time Frame: day 4 ]
    T_max

  4. half-life of drug in body [ Time Frame: day 4 ]
    T_1/2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects aged 18-45 years.
  • A body mass index (BMI or Quetlet index) in the range 18-30 kg/m^2, inclusive, and weighing between 50 and 100 kg at screening.

Body Mass Index (BMI) =weight[kg] / (height [m])^2

  • Willing to use a reliable method of contraception and not donate sperm during the study, and for 4 months afterwards.
  • Sufficient intelligence to understand the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with requirements of, the entire study.
  • Willing to give written consent to participate in the study after reading the ICF, and after having the opportunity to discuss the study with the Investigator or his delegate.
  • Willing to give written consent to have his data entered into The Over-volunteering Prevention System.

Exclusion Criteria:

  • Clinically relevant abnormal history, physical findings, ECG findings, or laboratory values that could interfere with the objectives of the study or compromise the safety of the subject.
  • Presence or history of acute or chronic illness, including (but not limited to) liver or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body-organ dysfunction.
  • History of serious reaction to any medicine.
  • Presence or history of malignant disease.
  • Acute or chronic infectious disease, including HIV, HBV or HCV infection.
  • Surgery (e.g. stomach bypass) or medical condition that might affect how the body handles or absorbs medicines.
  • Significant illness within 4 weeks before the dose of trial medication.
  • Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months, or unwilling to abstain from participating in other clinical trials during the study and for 3 months after receipt of trial medication.
  • Abnormal ECG waveform morphology at screening that would preclude accurate measurement of the QT interval duration.
  • QTcF interval duration > 430 msec, obtained as an average from the 3 ECG measurements on the triplicate screening ECGs.
  • Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m^2MDRD] equation).
  • Use of any prescription or OTC medications known to be strong inhibitors or strong inducers of CYP enzymes (also known as CYP P450 enzymes) during the 30 days before the dose of trial medication; use of any other prescription or OTC medicine including vitamins or herbal remedies like St John's wort, with the exception of acetaminophen (paracetamol), during the 7 days before the dose of trial medication.
  • Consumption of grapefruit, grapefruit juice or Seville oranges within 10 days before the dose of trial medication, or unwilling to abstain from consuming them throughout the study.
  • Consumption of food or beverages containing caffeine or xanthine within 24 h before admission on Day -1, or unwilling to abstain from consuming them for 3 days after receiving the trial medication.
  • Loss of more than 400 mL blood during the 3 months before the study.
  • Donation of blood, plasma, platelets, or any other blood components during the 3 months before the study, or unwilling to abstain from doing so during the study and for 3 months after receipt of trial medication.
  • Abuse of drugs or alcohol during the 2 years before the dose of trial medication, or intake of more than 21 units of alcohol weekly.
  • Use of tobacco products or nicotine-containing products during the 3 months before the dose of trial medication.
  • Evidence of drug or alcohol abuse at screening or admission.
  • Likely possibility that the volunteer will not cooperate with the requirements of the protocol.
  • Objection by GP to the volunteer entering the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107885


Locations
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United Kingdom
Hammersmith Medicines Research Ltd.
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02107885    
Other Study ID Numbers: DS1971-A-E101
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: October 2014
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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/