Relative Bioavailability DS-1971a Suspension and Tablets and Food Effect on DS-1971a Tablets

December 20, 2018 updated by: Daiichi Sankyo, Inc.

A Phase 1, Open Label, Randomised, Single Dose, Three Way Crossover Study to Explore the Relative Bioavailability of DS 1971a Given as a 200 mg Tablet Formulation and a 200 mg Oral Suspension, and to Explore the Effects of Administration With a High Fat Meal on the Relative Bioavailability of the Tablet Formulation

This is an open label, randomised, 3 treatment, 3 period crossover study. This study is designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a reconstituted oral suspension and the effect of a high fat meal on the relative bioavailability of DS 1971a from the tablet formulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW10 7EW
        • Hammersmith Medicines Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects aged 18 to 65 years, inclusive
  • Subjects must be in good general health as determined by medical history, physical examination and screening investigations, and be taking no regular medication
  • A body mass index (BMI) in the range 18 to 30 kg/m^2, inclusive, and weighing between 50 and 100 kg. BMI is calculated as weight [kg]/(height [m])^2
  • Female subjects must be of nonchildbearing 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 and able to consume a standard Food and Drug Administration (FDA) high fat meal
  • 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 study 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 study
  • Have given written consent to participate after reading the information and consent form, and after having the opportunity to discuss the study with the Investigator or his/her delegate
  • Have given written consent to have his/her data entered into The Over-volunteering Prevention System (TOPS)

Exclusion Criteria:

  • 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 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
  • 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
  • Significant illness within 4 weeks before the 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 studies during the study and for 3 months after receipt of their final dose 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 mmHg systolic, 40-90 mmHg 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%
  • Estimated glomerular filtration rate (eGFR) <80 mL/min/1.73m^2 or an absolute creatinine value above the upper limit of normal (ULN). eGFR will be estimated at Screening using the modification of diet in renal disease (MDRD) equation
  • 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
  • Use of any prescription medicine or 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 (also known as CYP450 enzymes) during the 30 days before the dose of study medication; use of any other prescription or OTC medicine, including dietary supplements or herbal remedies, during the 7 days before the first dose of study 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 study, eg, 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)
  • Use of tobacco products or nicotine containing products during the 3 months before the dose of trial medication
  • Likely possibility that the volunteer will not cooperate with the requirements of the protocol
  • Objection by General Practitioner (GP) to volunteer entering the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 200mg DS-1971a oral suspension fasted
200 mg DS 1971a given as oral suspension in fasted condition
Drug: DS-1971a suspension
DS 1971a will be supplied as a powder or crystals and prepared at the study site for administration as an oral suspension with a taste masking agent.
Experimental: 200 mg DS-1971a tablet fasted
single 200 mg DS 1971a oral tablet in fasted condition
Drug: DS-1971a tablet
A 200 mg DS 1971a tablet for oral administration
Experimental: 200 mg DS-1971a tablet fed
single 200 mg DS 1971a oral tablet given in fed condition
Drug: DS-1971a tablet
A 200 mg DS 1971a tablet for oral administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics profile of DS-1971a
Time Frame: 3 days from dose administration
Plasma concentration time data will be analysed using non compartmental methods. The following PK parameters will be estimated: Cmax, Tmax and AUClast. If data permit, AUC0-inf, CL/F, Vd/F and T½ will be estimated.
3 days from dose administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number and severity of adverse events as a measure of safety and tolerability
Time Frame: administration of first dose to 10 weeks
number and severity of adverse events as a measure of safety and tolerability
administration of first dose to 10 weeks
changes in clinical laboratory profile
Time Frame: administration of first dose to 10 weeks
haematology, biochemistry, and urinalysis
administration of first dose to 10 weeks
changes in physical exam profile
Time Frame: administration of first dose to 10 weeks
Physical examination profile includes; Height and weight, heart rate, blood pressure (BP), oral temperature and respiration rate, 12 lead electrocardiogram (ECG)
administration of first dose to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS1971-A-E104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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