SafetyPhase 1NCT02107885
Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.
A Phase 1 study testing DS-1971 in people with Safety and Tolerability, run by Daiichi Sankyo at 1 site in United Kingdom.
Trial summary
This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, Pharmacokinetics
- What is being tested?
- DS-1971
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Jul 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18-45 years.
- A body mass index (BMI or Quetlet index) in the range 18-30 kg/m^2, inclusive, and weighing between 50 and 100 kg at screening.
- Body Mass Index (BMI) =weight[kg] / (height [m])^2
- Willing to use a reliable method of contraception and not donate sperm during the study, and for 4 months afterwards.
- 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.
- Willing to give 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.
- Willing to give 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 HIV, HBV or HCV infection.
- Surgery (e.g. 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 dose of trial 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 trial medication.
- Abnormal ECG waveform morphology at screening that would preclude accurate measurement of the QT interval duration.
- QTcF interval duration > 430 msec, obtained as an average from the 3 ECG measurements on the triplicate screening ECGs.
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m^2MDRD] equation).
- Use of any prescription or OTC medications known to be strong inhibitors or strong inducers of CYP enzymes (also known as CYP P450 enzymes) during the 30 days before the dose of trial medication; use of any other prescription or OTC medicine including vitamins or herbal remedies like St John's wort, with the exception of acetaminophen (paracetamol), during the 7 days before the dose of trial medication.
- Consumption of grapefruit, grapefruit juice or Seville oranges within 10 days before the dose of trial medication, or unwilling to abstain from consuming them throughout the study.
- Consumption of food or beverages containing caffeine or xanthine within 24 h before admission on Day -1, or unwilling to abstain from consuming them for 3 days after receiving the trial medication.
- Loss of more than 400 mL blood during the 3 months before the study.
- Donation of blood, plasma, platelets, or any other blood components during the 3 months before the study, or unwilling to abstain from doing so during the study and for 3 months after receipt of trial medication.
- Abuse of drugs or alcohol during the 2 years before the dose of trial 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 dose of trial medication.
- 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.
United Kingdom1 site
Hammersmith Medicines Research Ltd.
London, NW10 7EW
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled Single Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male Subjects
This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by healthy male subjects.
- Conditions
- Safety, Tolerability, Pharmacokinetics
- Being tested
- DS-1971, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-1971Drug
6 subjects in each group will receive DS-1971.
placeboDrug
2 subjects in each group will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| DS-1971 | Experimental | single ascending dose of 5mg, 10mg, 30mg, 90mg, 250mg, 500mg, 1000mg, 1500mg. Receives: Drug: DS-1971 |
| placebo | Placebo comparator | placebo matching each of the DS-1971 dosages. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability adverse events
determine number, type, and severity of adverse events
Measured: 20 days after dose
safety and tolerability physical exam
determine adverse changes in vital signs, ECG.
Measured: 20 days after dose
safety and tolerability laboratory blood and urine tests
determine adverse changes in laboratory safety tests of blood (biochemistry and haematology) and urine.
Measured: from day 1 through 20 days after dose
Secondary outcomes (4)
plasma concentration AUC
concentration in blood measured as Area under the curve (AUC)
Measured: day 4
maximum blood concentration
Cmax
Measured: day 4
time of maximum blood concentration
T_max
Measured: day 4
half-life of drug in body
T_1/2
Measured: day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- 64 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
- NCT02107885
- Sponsor's protocol ID
- DS1971-A-E101
- Status last verified
- Oct 2014
- First submitted
- 4 Apr 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 1, Double-blind, Randomized, Placebo-controlled Single Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02107885
- Acronym / sponsor ID
- DS1971-A-E101
- Conditions
- Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Apr 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 and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by 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-1971 | Experimental | Drug: DS-1971single ascending dose of 5mg, 10mg, 30mg, 90mg, 250mg, 500mg, 1000mg, 1500mg. |
| placebo | Placebo comparator | Drug: placeboplacebo matching each of the DS-1971 dosages. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subjects aged 18-45 years.
- A body mass index (BMI or Quetlet index) in the range 18-30 kg/m^2, inclusive, and weighing between 50 and 100 kg at screening.
- Body Mass Index (BMI) =weight[kg] / (height [m])^2
- Willing to use a reliable method of contraception and not donate sperm during the study, and for 4 months afterwards.
- 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.
Key exclusion criteria (21 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 HIV, HBV or 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-19716 subjects in each group will receive DS-1971. | Drug | DS-1971 |
| placebo2 subjects in each group will receive placebo. | Drug | placebo |
Primary outcome
safety and tolerability adverse events
Time frame: 20 days after dose
determine number, type, and severity of adverse events
safety and tolerability physical exam
Time frame: 20 days after dose
determine adverse changes in vital signs, ECG.
safety and tolerability laboratory blood and urine tests
Time frame: from day 1 through 20 days after dose
determine adverse changes in laboratory safety tests of blood (biochemistry and haematology) and urine.
4 secondary outcomes
plasma concentration AUC
Time frame: day 4
maximum blood concentration
Time frame: day 4
time of maximum blood concentration
Time frame: day 4
half-life of drug in body
Time frame: day 4
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-1971 in people with Safety and Tolerability, 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 7 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 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?
safety and tolerability adverse events (time frame: 20 days after dose). The study lists 3 primary outcomes in all. 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.