AzTrials
AzTrials

Acute Ischemic StrokePhase 1NCT02071004

DS1040b/Aspirin Drug/Drug Interaction Study

A Phase 1 study testing DS-1040b and Aspirin in people with Acute Ischemic Stroke, 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
Search all trials

Trial summary

This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in healthy male and female subjects. It is hypothesized that co-administering DS-1040b with aspirin at steady state will be safe and well tolerated by healthy male and female subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
DS-1040b and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2014to Feb 2014
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and female subjects, aged 18 to 45 years.
  • A body mass index (BMI, or Quetlet index) in the range of 18.0 to 30.0 kg/m2, and weighing between 50 and 100 kg at screening.
  • Male subjects have to agree to contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another form of contraception (e.g., an intrauterine device, diaphragm with spermicide, oral contraceptive, injectable, or sub dermal hormonal implant) from the first dose until 16 weeks following the last dose administration. Also, the male subjects must not donate sperm after the study for a period of four months.
  • All women must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission (Day -1). Women must be of non-childbearing potential either: Surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) or naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at screening of ≥ 40 mIU/mL.
  • Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire trial.
  • Willingness to give written consent to participate after reading the ICF, and after having the opportunity to discuss the trial with the Investigator or his delegate.
Show all 9Show fewer
  • Willingness to give written consent to have data entered into The Overvolunteering Prevention Scheme.
  • Willing to abstain from grapefruit/grapefruit juice and Seville oranges from 7 days before the first dose and throughout the study.
  • Willing to refrain from consuming food or beverages containing caffeine/xanthine starting 24 hours prior to check-in on Day -1.

Who cannot join

  • Clinically relevant abnormal history, including cardiovascular, haematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic (including previous transient ischemic attack or stroke), and psychiatric diseases, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
  • History of a serious reaction to any medicine.
  • History of major bleeding, stomach ulcer, Raynaud's disease, major trauma, or major surgical procedure of any type within 6 months of dosing.
  • History of minor bleeding episodes such as epistaxis, rectal bleeding (spots of blood on toilet paper), and gingival bleeding within 3 months before the study treatment.
  • Familial or documented or suspected coagulopathy and haemoglobinopathy.
  • Females with a history of dysfunctional uterine bleeding, including history of menorrhagia, metrorrhagia, or polymenorrhea.
Show all 28Show fewer
  • History of an operation (e.g. stomach bypass), or a condition that could affect how the body handles or absorbs medicines.
  • History of gastro-oesophageal reflux disease.
  • Females who are breastfeeding.
  • Positive urine or faecal occult blood test at screening or admission (Day -1 or day 1).
  • Bleeding time > 9.5 minutes at screening).
  • aPTT, PT, INR, or platelet count outside the limit of normal of the clinical laboratory's reference range at screening.
  • Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 (based on Modification of Diet in Renal Disease [MDRD] equation).
  • Positive test for hepatitis B, hepatitis C, HIV1 \& HIV2.
  • QTcF interval duration > 430 msec for males and 450 msec for females, obtained as an average from the 3 ECG measurements on the triplicate screening ECGs.
  • Abnormal waveform morphology on any of the ECGs at screening at admission that would preclude accurate measurement of the QT interval duration.
  • Physical trauma, dental extraction, surgery, or a significant illness within 4 weeks before the first dose.
  • History or presence of keloid, hyperpigmentation, or other adverse reaction to skin injury or surgery.
  • Use of any prescribed or non-prescribed (over-the-counter [OTC]) systemic medications (including anticoagulants or antiplatelet medications), topical medications, or herbal supplements within 14 days before the first dose (excluding paracetamol ≤ 2 g/day). St. John's Wort (hypericin) must not have been taken for at least 30 days before the first dose.
  • Donated or lost > 400 mL of blood or plasma during 3 months before the first dose on Day 1.
  • Donation of blood, plasma, platelets, or any other blood components during the 3 months before the trial, or unwilling to abstain from doing so during the study and for 3 months after receipt of trial medication.
  • Participated in a clinical study involving administration of an investigational drug, or a marketed drug within 90 days before administration of the first dose.
  • Male subjects who consume more than 21 units of alcohol per week or female subjects who consume more than 14 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, a glass of wine, or 1 measure of spirits) or those subjects who have a significant history of alcoholism or drug/chemical abuse within the last 2 years.
  • Use of tobacco products or nicotine-containing products within 3 months before the first dose.
  • Positive results on tests for drugs of abuse, carbon monoxide, or alcohol at screening or admission.
  • Possibility that the volunteer will not cooperate with the requirements of the protocol.
  • Objection by General Practitioner (GP) to volunteer entering the trial.
  • Known aspirin allergy or intolerance.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hammersmith Medicines Research Ltd.

    London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: A PHASE 1, OPEN LABEL, SINGLE DOSE STUDY, TO ASSESS THE SAFETY AND TOLERABILITY OF A SINGLE IV DOSE OF DS-1040B AFTER 5 DAYS OF ASPIRIN TREATMENT IN HEALTHY SUBJECTS

This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in healthy male and female subjects. It is hypothesized that co-administering DS-1040b with aspirin at steady state will be safe and well tolerated by healthy male and female subjects.

Being tested
DS-1040b, Aspirin
Keywords
acute ischemic stroke
Medical subject headings
Ischemic Stroke

What participants receive

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

  • DS-1040bDrug

    IV of 6 mg given once over 30 minutes

  • AspirinDrug

    Dispersible tablet, 300mg \& 75 mg, once daily for 5 days

Study groups in NCT02071004
Study groupRoleWhat they receive
AspirinOtherDispersible tablet, 300mg \& 75 mg, once daily for 5 days
Receives: Drug: Aspirin
DS-1040bExperimentalIV of 6 mg given once over 30 minutes
Receives: Drug: DS-1040b

What is being measured

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

  1. bleeding time

    To assess the safety (including bleeding time) and tolerability of a single IV dose of DS-1040b following 5 days aspirin treatment in healthy subjects

    Measured: day 0 to day 5 after dosing

Secondary outcomes (5)

  1. change in D-dimer level

    To assess the effect of a single IV dose of DS-1040b following 5 days aspirin treatment on D-dimer levels

    Measured: day 0 - day 5 after dosing

  2. Cmax

    Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods. The following parameters will be estimated and reported:

    .

    Measured: Days 5, 6, and 7 after dosing

  3. Tmax

    Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods. The following parameters will be estimated and reported:

    Measured: Days 5, 6, and 7 after dosing

  4. AUC

    Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods. The following parameters will be estimated and reported:

    Measured: Days 5, 6, and 7 after dosing

  5. half-life

    Plasma concentration time data of DS-1040a (the free form of DS-1040b) will be analyzed using non-compartmental methods. The following parameters will be estimated and reported:

    Measured: Days 5, 6, and 7 after dosing

Timeline

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

  1. First posted25 Feb 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02071004
Sponsor's protocol ID
DS1040-A-E102
Status last verified
Feb 2014
First submitted
21 Feb 2014
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/

Publications

  • Limsakun T, Dishy V, Mendell J, Pizzagalli F, Pav J, Kochan J, Vandell AG, Rambaran C, Kobayashi F, Orihashi Y, Warren V, McPhillips P, Zhou J. Safety and Pharmacokinetics of DS-1040 Drug-Drug Interactions With Aspirin, Clopidogrel, and Enoxaparin. J Clin Pharmacol. 2020 Jun;60(6):691-701. doi: 10.1002/jcph.1568. Epub 2020 Feb 27.

    PubMed 32106339

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-1040b and Aspirin in people with Acute Ischemic Stroke, 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 9 inclusion and 28 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?

bleeding time (time frame: day 0 to day 5 after dosing). 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 NCT02071004, which also lists 1 linked publication.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in