HealthyPhase 1NCT02190058
Multiple Dose Study of DS-1971a
A Phase 1 study testing DS-1971a in people with Healthy, run by Daiichi Sankyo at 1 site in United Kingdom.
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 subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DS-1971a
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18-55 years.
- A body mass index (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 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 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.
Show all 20Show fewer
- 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.
- Participation in another clinical study with DS 1971a.
- 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, obtained as an average from the measurements on duplicate screening ECGs.
- 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.
- 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.
- 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 GP to the volunteer entering the study.
Trial locations and contacts
1 site in 1 country.
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 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 subjects.
- Conditions
- Healthy
- Being tested
- DS-1971a, placebo
- Keywords
- safety, pharmacokinetics, DS-1971a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-1971aDrug
suspension
placeboDrug
placebo matching DS-1971a
| Study group | Role | What they receive |
|---|---|---|
| DS-1971a | Experimental | DS-1971a suspension, up to 4650mg/day Receives: Drug: DS-1971a |
| placebo | Placebo comparator | matching DS-1971a suspension Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
To assess the safety and tolerability of repeated oral doses of DS-1971a in healthy male subjects the number, severity, and frequency of adverse events will be recorded from enrollment through discharge from study, up to 2 months.
Measured: up to 2 months
Secondary outcomes (6)
characterise the plasma pharmacokinetics AUC (area under curve)
To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
Measured: Day 1 through Day 17
characterise the plasma pharmacokinetics Cmax (maximum concentration)
To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
Measured: Day 1 through Day 17
characterise the plasma pharmacokinetics Tmax (time of maximum concentration)
To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
Measured: Day 1 through Day 17
characterise the plasma pharmacokinetics T½ (terminal half-life)
To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
Measured: Day 1 through Day 17
characterise the plasma pharmacokinetics CL/F (apparent oral clearance)
To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F (apparent oral clearance); Vss/F
Measured: Day 1 through Day 17
characterise the plasma pharmacokinetics Vss/F (apparent volume of distribution)
To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F (apparent oral clearance); Vss/F (apparent volume of distribution).
Measured: Day 1 through Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190058
- Sponsor's protocol ID
- DS1971-A-E102
- Status last verified
- Jan 2015
- First submitted
- 11 Jul 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/
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 SUBJECTS
- ClinicalTrials.gov ID
- NCT02190058
- Acronym / sponsor ID
- DS1971-A-E102
- Conditions
- Healthy
- Keywords
- safety, pharmacokinetics, DS-1971a
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS-1971a | Experimental | Drug: DS-1971aDS-1971a suspension, up to 4650mg/day |
| placebo | Placebo comparator | Drug: placebomatching DS-1971a suspension |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subjects aged 18-55 years.
- A body mass index (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 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-1971asuspension | Drug | DS-1971a |
| placeboplacebo matching DS-1971a | Drug | placebo |
Primary outcome
adverse events
Time frame: up to 2 months
To assess the safety and tolerability of repeated oral doses of DS-1971a in healthy male subjects the number, severity, and frequency of adverse events will be recorded from enrollment through discharge from study, up to 2 months.
6 secondary outcomes
characterise the plasma pharmacokinetics AUC (area under curve)
Time frame: Day 1 through Day 17
characterise the plasma pharmacokinetics Cmax (maximum concentration)
Time frame: Day 1 through Day 17
characterise the plasma pharmacokinetics Tmax (time of maximum concentration)
Time frame: Day 1 through Day 17
characterise the plasma pharmacokinetics T½ (terminal half-life)
Time frame: Day 1 through Day 17
characterise the plasma pharmacokinetics CL/F (apparent oral clearance)
Time frame: Day 1 through Day 17
characterise the plasma pharmacokinetics Vss/F (apparent volume of distribution)
Time frame: Day 1 through Day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 6 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. Some participants in this study may receive a placebo. 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?
adverse events (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 last refreshed its copy on 31 Oct 2026.