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HealthyPhase 1NCT02261376

Effects of Age, Gender & Race on the Pharmacokinetics (PK)of DS-1971a

A Phase 1 study testing DS-1971a 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

This is an open label, non-randomised, single-dose, parallel-group study in 48 healthy subjects enrolled in 4 cohorts - Caucasian men, aged 18-55 years, Caucasian men, aged 65 years or older, Japanese men, aged 18-55 years, Caucasian women, aged 18-55 years. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
DS-1971a
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2014to Nov 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy volunteers:
  • Cohort 1: Caucasian men, aged 18-55 years
  • Cohort 2: Caucasian men, 65 years and older
  • Cohort 3: Japanese men, aged 18-55 years
  • Cohort 4: Caucasian women, aged 18-55 years For the purpose of determining eligibility, age is calculated at the day of dose administration
  • Caucasian subjects (Cohorts 1-2 and 4) must have 4 Caucasian grandparents.
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  • Japanese subjects (Cohort 3 only) must have 4 ethnically Japanese grandparents, have a Japanese passport, and have lived outside Japan for no longer than 5 years.
  • Female subjects (Cohort 4 only) must be of non-childbearing potential, as follows:
  • they must be post-menopausal (the last menstrual period was at least 12 months ago, and a follicle-stimulating hormone (FSH) test at screening confirms post menopausal status); or
  • they must be surgically sterile, that is undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation.
  • A BMI in the range 18-30 kg/m2, inclusive, and weighing between 50 and 100 kg at screening.
  • Willing to comply with all study restrictions, including the use of contraception, concomitant medication, and dietary and lifestyle restrictions.
  • 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.
  • Have given written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his/her delegate.
  • 9. Have given written consent to have his/her data entered into The Over-volunteering Prevention System (TOPS).

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 of 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.
  • Presence or history of severe adverse reaction to any medicine.
  • Presence or history of malignant disease.
  • Acute or chronic infectious disease, including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or C virus (HCV) infection.
  • Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
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  • Significant illness within 4 weeks before the dose of study 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 study medication.
  • Participation in another clinical study with DS-1971a.
  • Blood pressure (BP) and heart rate in semi-supine position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min. Subjects with Stage 1 hypertension (systolic 140-160 mmHg; diastolic 90-100 mmHg) may be enrolled provided they do not have evidence of end-organ damage, diabetes or a 10 year cardiovascular risk >20%.
  • Abnormal ECG waveform morphology at screening that would preclude accurate measurement of the QT interval duration.
  • Corrected QT interval (Fridericia's formula) (QTcF) interval duration > 430 msec for men or > 450 msec for women, obtained as an average from the measurements on duplicate screening ECGs.
  • Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 (younger subjects, Cohorts 1, 3 and 4) or < 70 mL/min/1.73 m2 (older subjects, Cohort 2) or an absolute creatinine value above the upper limit of the normal range. eGFR will be estimated using the modification of diet in renal disease [MDRD] equation).
  • Use of any prescription medicine or over the counter (OTC) medications, or herbal remedies (such as St John's wort), known to be strong inhibitors or strong inducers of cytochrome (CYP) enzymes (also known as CYP450 enzymes) during the 30 days before the dose of trial medication; use of any other prescription or OTC medicine (except as permitted), including dietary supplements or herbal remedies, during the 7 days before the first dose of trial medication.
  • Consumption of certain foods or beverages before the dose and throughout the study period.
  • Loss of more than 400 mL blood during the 3 months before the trial, e.g., as a blood donor.
  • Abuse of drugs or alcohol during the 2 years before the first dose of study medication, or intake of more than 21 units of alcohol weekly (for men) or 14 units of alcohol weekly (for women).
  • Smoking more than 10 cigarettes or ½ ounce of tobacco daily and unwilling to stop smoking during the study.
  • Likely possibility that the volunteer will not cooperate with the requirements of the protocol.
  • Objection by General Practitioner (GP) to volunteer entering the study.

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

This is an open label, non-randomised, single-dose, parallel-group study in 48 healthy subjects enrolled in 4 cohorts - Caucasian men, aged 18-55 years, Caucasian men, aged 65 years or older, Japanese men, aged 18-55 years, Caucasian women, aged 18-55 years.

Conditions
Healthy
Being tested
DS-1971a
Keywords
pharmacokinetics

What participants receive

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

  • DS-1971aDrug

    DS-1971a is supplied as a powder or crystals and will be given as an oral suspension with Bitrex® (taste masking agent). Each subject will receive a single oral dose of 200 mg DS 1971a .

Study groups in NCT02261376
Study groupRoleWhat they receive
Caucasian men, aged 18-55 yearsExperimentalNot described
Receives: Drug: DS-1971a
Caucasian men, aged 65 years or olderExperimentalNot described
Receives: Drug: DS-1971a
Japanese men, aged 18-55 yearsExperimentalNot described
Receives: Drug: DS-1971a
Caucasian women, aged 18-55 yearsExperimentalNot described
Receives: Drug: DS-1971a

What is being measured

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

  1. Pharmacokinetic (PK) Profile of DS-1971a

    PK: plasma concentrations of DS-1971a, and derived PK parameters: Cmax, tmax, tlast, t½, AUC0-inf, AUClast, %AUCextr, λz, Vz/F and CL/F.

    Measured: 4 days after dose administered

Secondary outcomes (3)

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Number and severity of events will be measured and reported.

    Measured: 4 days after dose administered

  2. changes in laboratory profile as a measure of safety and tolerability

    clinically significant changes in blood and urine will be measured and reported (haemoglobin (Hb), red blood cells (RBC), mean corpuscular volume (MCV), mean corpuscular Hb (MCH), mean corpuscular Hb concentration (MCHC), haematocrit (HCT), white blood cells (WBC) and differential, platelets, urea, creatinine, uric acid, eGFR (only at screening), total bilirubin, total protein, albumin, globulin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma GT), glucose, phosphate, cholesterol, triglycerides, potassium, sodium, calcium, chloride)

    Measured: 4 days after dose administered

  3. change in ECG profile

    clinically significant changes in ECG profile (such as QTc, PR interval, Ventricular rate, QRS) will be measured and reported

    Measured: 4 days after dose administered

Timeline

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

  1. First posted10 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2014
  4. Study completionNov 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
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02261376
Sponsor's protocol ID
DS1971-A-E103
Status last verified
Jan 2015
First submitted
1 Oct 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-1971a 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 15 inclusion and 20 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?

Pharmacokinetic (PK) Profile of DS-1971a (time frame: 4 days after dose administered). 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 NCT02261376.

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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