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HealthyPhase 1NCT02647307

Study of the Effects of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of DS-1040b

A Phase 1 study testing DS-1040b in people with Healthy, run by Daiichi Sankyo at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed study is not hypothesis testing but is intended to explore the effects of different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b. Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
DS-1040b
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
Feb 2016to Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects aged ≥ 18 years to 60 years, inclusive.
  • Caucasian, Japanese, Chinese and Korean must have both parents and all 4 grandparents of equivalent descent.
  • Subjects with a body mass index (BMI) of ≥ 18 kg/m2 to 30 kg/m2, inclusive, and weighing ≥ 50 kg to 100 kg, inclusive. BMI is calculated as weight [kg]/(height [m])2.
  • Subjects must be in good health as determined by medical history, physical examination and Screening investigations, and taking no regular medication.
  • Willing to comply with all study restrictions, including the use of contraception, concomitant medication and dietary and lifestyle restrictions.
  • Possessing sufficient intelligence to understand the nature of the study and any hazards of participating in it, and the ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire study.
  • Has given written consent to participate after reading the informed consent form (ICF), and after having the opportunity to discuss the study with the Investigator or delegate.
  • Have given written consent to have his data entered into The Overvolunteering Prevention System.

Who cannot join

  • Clinically relevant abnormal history, physical findings, ECG findings or laboratory values that could interfere with the objectives of the study or the safety of the subject.
  • Presence or history of acute or chronic illness, including (but not limited to) liver (Gilbert's Syndrome is permitted) or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body organ dysfunction.
  • Presence or history of severe adverse reaction to any medicine.
  • Presence or history of malignant disease.
  • Significant illness within 4 weeks before the dose of study medication.
  • Dosed 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 study medication.
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  • Participation in another clinical study with DS-1040b.
  • Blood pressure (BP) and heart rate (HR) in semi supine position at the Screening examination outside the ranges 90 mmHg to 140 mmHg systolic, 40 mmHg to 90 mmHg diastolic; HR 40 beats/min to 100 beats/min. A subject with vital signs values outside the reference range for the population being studied may be included at the Investigator's discretion if it is unlikely to introduce additional risk factors and will not interfere with study procedures.
  • Abnormal ECG waveform morphology at Screening that would preclude accurate measurement of the uncorrected QT interval (QT) duration.
  • QT interval for HR corrected using Fridericia's formula (QTcF) interval duration > 430 msec obtained as an average from the measurements on triplicate Screening ECGs.
  • Use of any prescription medicine, over the counter (OTC) medications, herbal remedies (such as St John's Wort), or food known to be strong inhibitors or strong inducers of cytochrome (CYP) enzymes during the 30 days before the dose of study medication; use of any other prescription or OTC medicine (except as permitted), including dietary supplements or herbal remedies, during the 7 days before receiving study medication.
  • Consumption of certain foods or beverages before the dose and throughout the study period
  • Loss of more than 400 mL blood (or plasma), or donation of platelets or other blood components during the 3 months before the dose of study medication, or unwilling to abstain from doing so during the study and for 3 months after receipt of study medication.
  • Abuse of drugs or alcohol in the past, or intake of more than 21 units of alcohol weekly.
  • Moderate to heavy use of tobacco products or nicotine containing products (eg ≥ 5 cigarettes per day during the 3 months before the dose of study medication.
  • Male subjects have to agree to use 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 receiving study medication until 4 months following the dose administration. Also, male subjects must not donate sperm until at least 4 months following the last dose administration.
  • Evidence of acute or chronic infectious disease at Screening, including: positive Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) antibody, or Human Immunodeficiency Virus (HIV) antibody.
  • Subjects who have used anticoagulants (ie, warfarin, low molecular weight heparin, thrombin inhibitors), antiplatelet medication (eg, clopidogrel), and/or aspirin within 30 days prior to Day 1.
  • Subjects with any history of major bleeding or major surgical procedure of any type within 6 months before Day 1.
  • Subjects with any history of peptic ulcer, gastrointestinal bleeding including haematemesis, melena, or bleeding from haemorrhoids.
  • Subjects with a history of minor bleeding episodes such as epistaxis, rectal bleeding (spots of blood on toilet paper), or gingival bleeding within 3 months before Day 1.
  • Subjects who have any family history, suspected or documented, of coagulopathy or haemoglobinopathy or evidence of abnormal coagulation parameters (eg, Prothrombin Time PT, International Normalised Ratio INR or Activated Partial Thromboplastin Time aPTT) at Screening. Subjects with borderline values for PT, INR or aPTT can be enrolled if the abnormality is considered not clinically significant by the investigator.
  • Subjects with an estimated glomerular filtration rate (eGFR) at Screening using the MDRD (Modification of Diet in Renal Disease) equation < 90 mL/min.
  • Likely possibility that the subject will not cooperate with the requirements of the protocol.
  • Objection by General Practitioner to subjects entering the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hammersmith Medicines Research

    London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: A Phase I, Open Label, Parallel Group Study to Evaluate the Effect of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of a DS 1040b IV Infusion Administered to Healthy Male Subjects

The proposed study is not hypothesis testing but is intended to explore the effects of different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b.

Subjects entering the study will receive a single 12 hour infusion of DS-1040b and be followed up to assess the effects on ethnicity on blood levels of DS-1040b as well as safety \& tolerability.

Conditions
Healthy
Being tested
DS-1040b

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-1040bDrug

    Single 12-hour intravenous infusion of DS-1040b (20 mg)

Study groups in NCT02647307
Study groupRoleWhat they receive
DS-1040bExperimentalSingle 12-hour intravenous infusion of DS-1040b (20 mg).
Receives: Drug: DS-1040b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentrations of DS-1040

    Plasma concentrations of DS-1040 and derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040.

    Measured: Day 1 to Day 6

  2. Cmax Concentration Maximum

    derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

    Measured: Day 1 to Day 6

  3. Tmax time of maximum concentration

    derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

    Measured: Day 1 to Day 6

  4. AUC Area under curve

    derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

    Measured: Day 1 to Day 6

  5. C12h concentration in plasma 12 hours after infusion

    derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

    Measured: Day 1 to Day 6

Secondary outcomes (8)

  1. number and severity of adverse events

    safety and tolerability

    Measured: Day 1 to Day 6

  2. number and severity of changes in clinical laboratory findings

    safety and tolerability

    Measured: Day 1 to Day 6

  3. number and severity of changes in physical exam findings

    safety and tolerability

    Measured: Day 1 to Day 6

  4. number and severity of changes in vital sign findings

    safety and tolerability

    Measured: Day 1 to Day 6

  5. number and severity of changes in 12-lead electrocardiogram ECG findings

    safety and tolerability

    Measured: Day 1 to Day 6

  6. change from baseline in thrombin activatable fibrinolysis inhibitor activity

    Change in baseline of pharmacodynamic parameters (thrombin activatable fibrinolysis inhibitor activity, clot lysis, plasma D-dimer) up to 6 days post dose.tolerability

    Measured: Day 0 (baseline) to Day 6

  7. change from baseline in clot lysis

    Change in baseline of pharmacodynamic parameters (thrombin activatable fibrinolysis inhibitor activity, clot lysis, plasma D-dimer) up to 6 days post dose.tolerability

    Measured: Day 0 (baseline) to Day 6

  8. change from baseline in plasma D-dimer

    Change in baseline of pharmacodynamic parameters (thrombin activatable fibrinolysis inhibitor activity, clot lysis, plasma D-dimer) up to 6 days post dose.tolerability

    Measured: Day 0 (baseline) to Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02647307
Sponsor's protocol ID
DS1040-A-E108
Other IDs
2015-003470-32, 2015
Status last verified
Aug 2016
First submitted
4 Jan 2016
Last updated
24 Dec 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-1040b in people with Healthy, run by Daiichi Sankyo at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentrations of DS-1040 (time frame: Day 1 to Day 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02647307.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.

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