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HealthyPhase 1NCT02564861

Multiple Dose Study of D1971a in Healthy Volunteers

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 a randomised, double-blind, placebo-controlled multiple dose study designed to explore the safety, tolerability and PK of DS-1971a following oral administration over 14 days to healthy male and female subjects. Each participant receives lidocaine as a local anaesthetic before inserting the intravenous cannula. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy 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?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2015to Dec 2015
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male and female subjects aged 18 years to 65 years.
  • A body mass index (BMI) in the range 18 kg/m2 to 30 kg/m2, inclusive, and weighing between 50 kg and 100 kg, inclusive at screening. BMI is calculated as weight [kg]/(height [m])2.
  • Female subjects must be of non-childbearing potential as follows:
  • Must be postmenopausal (the last menstrual period was at least 12 months before Screening, and a follicle stimulating hormone [FSH] test at Screening confirms postmenopausal status); or
  • Must be surgically sterile having undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation.
  • Willing to comply with all study restrictions, including the use of contraception, concomitant medication, and dietary and lifestyle restrictions.
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  • 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.
  • Have given 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.
  • Have given written consent to have his/her data entered into The Over volunteering 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 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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) or C virus (HCV) infection.
  • Surgery (eg, stomach bypass) or medical condition that might affect how the body handles or absorbs medicines.
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  • Significant illness within 4 weeks before the first dose of study medication.
  • Participation in another clinical study 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.
  • Blood pressure (BP) and heart rate in semi-supine position at the Screening examination outside the ranges 90 mmHg to 140 mmHg systolic, 40 mmHg to 90 mmHg diastolic; heart rate < 40 beats/min to > 100 beats/min. Subjects with Stage 1 hypertension (systolic 140 mmHg to 160 mmHg; diastolic 90 mmHg to 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 uncorrected QT interval (QT) duration.
  • QT interval for heart rate corrected using QTcF interval duration > 430 ms for men or > 450 ms for women, obtained as an average from the measurements on duplicate Screening ECGs over a brief recording period.
  • Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73m2 (based on Modification of Diet in Renal Disease [MDRD] equation) or an absolute creatinine value outside the normal range.
  • Use of any prescription 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 CYP P450 enzymes) during the 30 days before the first dose of study medication; use of any other prescription or OTC medicine (with the exception of acetaminophen (paracetamol)), including dietary supplements or herbal remedies, during the 7 days before the dose of study medication.
  • Pregnant or breastfeeding women.
  • Consumption of certain foods or beverages before the first dose and throughout the study period.
  • Loss of more than 400 mL blood or donation of blood, plasma, platelets, or any other blood components during the 3 months before the first 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 during the 2 years before the first dose of study medication, or intake of more than 21 units of alcohol weekly for male subjects and 14 units of alcohol weekly for female subjects.
  • Use of tobacco products or nicotine-containing products during the 3 months before the first dose of study medication and during the study.
  • 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 General Practitioner (GP) to the volunteer entering the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Mammersmith Medicines Research Ltd.

    London

Other trials in United Kingdom

About this study

Official title: A Phase I, Double-Blind, Randomised, Placebo Controlled, Multiple-Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male and Female Subjects

This is a randomised, double-blind, placebo-controlled multiple dose study designed to explore the safety, tolerability and PK of DS-1971a following oral administration over 14 days to healthy male and female subjects. Each participant receives lidocaine as a local anaesthetic before inserting the intravenous cannula.

Read the detailed description

Within strictly defined limits, the protocol permits the dose escalation committee to amend the dose escalation rules, doses proposed in the study protocol and to change the timing of or to add additional assessments following review of the safety, tolerability and plasma DS-1971a concentration data. The decisions to change the doses will be documented in the minutes of the dose escalation committee.

Conditions
Healthy
Being tested
DS-1971a, Placebo
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

  • PlaceboDrug

    Placebo matching DS-1971a suspension

Study groups in NCT02564861
Study groupRoleWhat they receive
DS-1971a (Low Dose)ExperimentalParticipants in Cohort 1 who receive a low dose of DS 1971a in an oral suspension
Receives: Drug: DS-1971a
DS-1971a (Mid dose)ExperimentalParticipants in Cohort 2 who receive a mid dose of DS 1971a in an oral suspension
Receives: Drug: DS-1971a
DS-1971a (High dose)ExperimentalParticipants in Cohort 3 who receive a high dose of DS 1971a in an oral suspension
Receives: Drug: DS-1971a
Pooled placeboExperimentalParticipants in Cohort 1, 2 or 3 who receive matching DS-1971a Placebo
Receives: Drug: Placebo

What is being measured

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

  1. Number of participants with at least one Treatment Emergent Adverse Event (TEAEs)

    TEAEs are adverse events that began or got worse after treatment began. Clinically significant changes in laboratory tests and/or physical examinations are considered adverse events.

    Measured: 14 days

Secondary outcomes (7)

  1. Cmax of DS-1971a

    Cmax is the highest concentration of the drug in the blood

    Measured: Day 1 and Day 14

  2. Tmax of DS-1971a

    Tmax is the time it takes for Cmax to be reached

    Measured: Day 1 and Day 14

  3. Area Under Curve at steady state (AUCtau) of DS-1971a

    AUCtau is the area under the plasma concentration-time curve at steady state. In pharmacokinetics, steady state refers to the situation where the overall intake of a drug is about even with the rate it is being eliminated from the body.

    Measured: Day 1 and Day 14

  4. Area under the Curve (additional measures) for DS-1971a

    Additional AUC measures include AUC0-24 (to 24 hours), AUClast (to the last observable measure), AUC0-inf (to infinity), and AUCextr (from AUClast to infinity)

    Measured: Day 1 and Day 14

  5. Tmax of DS-1971a metabolites M1 and M2

    Tmax of metabolites M1 and M2 characterized by Tmax

    Measured: Day 1 and Day 14

  6. Cmax of DS-1971a metabolites M1 and M2

    Cmax of metabolites M1 and M2 characterized by Cmax

    Measured: Day 1 and Day 14

  7. AUC of DS-1971a metabolites M1 and M2

    AUC measures include AUCtau, AUC0-24, AUClast, AUC0-inf

    Measured: Day 1 and Day 14

Timeline

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

  1. First posted1 Oct 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02564861
Sponsor's protocol ID
DS1971-A-E106
Other IDs
2015-002885-22, 2015
Status last verified
Apr 2017
First submitted
28 Sep 2015
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
No

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 9 inclusion and 21 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 28 Apr 2017. 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?

Number of participants with at least one Treatment Emergent Adverse Event (TEAEs) (time frame: 14 days). 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 NCT02564861.

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 28 Apr 2017.

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