AnaemiaPhase 1NCT02142400
Multiple Ascending Dose Study of DS-1093 in Healthy Subjects
A Phase 1 study testing DS-1093 in people with Anaemia, run by Daiichi Sankyo at 1 site in United Kingdom.
Trial summary
This is a randomised, double-blind, placebo-controlled multiple ascending single study. It is hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week treatment period and will result in increases in reticulocyte count and haemoglobin concentrations in healthy male volunteers 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
- Anaemia
- What is being tested?
- DS-1093
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Feb 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 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 Quetelet index) in the range 18.0-30.0
- Willing to use a reliable method of contraception during the trial, and for 4 months afterwards
- 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.
- Willingness to give written consent to participate after reading the information and consent form (ICF), and after having the opportunity to discuss the trial with the Investigator or his delegate.
- Willingness to give written consent to have data entered into The Overvolunteering Prevention System.
Who cannot join
- Clinically relevant abnormal medical history, physical findings, electrocardiogram (ECG), or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Presence of acute or chronic illness or history of chronic illness (particularly hypertension, seizures, kidney disease or liver disease, including known or newly discovered Gilbert's syndrome) sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of psychotic mental illness.
- Presence or history of malignant disease, other than basal cell carcinoma that was successfully treated at least 5 years ago.
- Any medical history that, in the opinion of the Investigator, is suggestive of a significant bleeding or coagulation risk.
- History of venous or arterial thrombosis or embolic disease.
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- History of gastric or duodenal ulcer.
- History of treatment with, or use of, an erythropoiesis stimulating agent (e.g. EPO).
- Blood pressure (BP) and heart rate in 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.
- Haemoglobin concentration of < 129 g/L, platelets outside the normal reference ranges at the screening examination, or evidence of iron deficiency based on serum iron and ferritin levels.
- Surgery (e.g. stomach bypass) or medical condition that might affect absorption of medicines.
- Presence or history of significant hypersensitive or allergic reaction to any drug, except penicillin.
- Use of a prescription medicine or a strong inducer or inhibitor of cytochrome P450 enzymes, during the 30 days before the first dose of trial medication; use of any other over-the-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days before the first 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 the final dose of trial medication.
- Positive test for hepatitis B, hepatitis C, HIV 1 \& HIV 2.
- Abuse of drugs or alcohol during the 2 years before the first dose of trial medication.
- Evidence of drug or alcohol abuse at screening, or intake of more than 21 units of alcohol weekly.
- Use of tobacco or nicotine-containing products during the 3 months before the first dose of trial medication.
- Loss of more than 400 mL blood, or donation of blood, plasma, platelets, or any other blood components, during the 3 months before the trial, or unwilling to abstain from donating during the study and for 3 months after receipt of the final dose of trial medication.
- Possibility that the volunteer will not cooperate with the requirements of the protocol.
- Objection by General Practitioner (GP) to volunteer entering trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomised, Placebo-controlled, Multiple Ascending-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DS 1093a in Healthy Male Subjects
This is a randomised, double-blind, placebo-controlled multiple ascending single study. It is hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week treatment period and will result in increases in reticulocyte count and haemoglobin concentrations in healthy male volunteers
- Conditions
- Anaemia
- Being tested
- DS-1093, placebo
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-1093Drug
DS-1093 in capsules with 2.5mg or 25mg per capsule
placeboDrug
matching placebo capsules to DS-1093 capsules
| Study group | Role | What they receive |
|---|---|---|
| DS-1093 | Experimental | Group 1 will receive 10mg, group 2 will receive 25mg of DS-1093 Receives: Drug: DS-1093 |
| placebo | Placebo comparator | placebo to match DS-1093 dosage Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood concentration of DS-1093
level of DS-1093 will be determined in participants blood from the time of initial dosing through 15 days after.
Measured: time of dosing through Day 15
number of adverse events including type and severity
number, type and severity of adverse events will be reported during the study from initial randomization through Day 98
Measured: date of randomization through Day 98
Secondary outcomes (11)
levels of EPO
Pharmacodynamic (PD) analyses will be conducted for EPO (Erythropoietin ) through 42 days after initial dosing
Measured: time of dosing through 42 days after dosing
levels of VEGF
Pharmacodynamic (PD) analyses will be conducted forVEGF (Vascular Endothelial Growth Factor) through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of H25
Pharmacodynamic (PD) analyses will be conducted for H25 (Hepcidin-25); through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of Reticulocytes
Pharmacodynamic (PD) analyses will be conducted for hematology markers {RET (Reticulocytes), through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of Haemoglobin
Pharmacodynamic (PD) analyses will be conducted for hematology markers Hb (haemoglobin), through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of Haematocrit
Pharmacodynamic (PD) analyses will be conducted for hematology markers HCT (haematocrit), through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of Red Blood Cells
Pharmacodynamic (PD) analyses will be conducted for hematology marker RBC (red blood cells) through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of Serum Iron
Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker {SI (Serum Iron) through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of Transferrin
Pharmacodynamic (PD) analyses will be conducted for iron metabolism markers T (Transferrin), through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of TSAT
Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker TSAT(Saturated Transferrin) through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
levels of Ferrin
Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker F (Ferritin) through 42 days of dosing.
Measured: time of dosing through 42 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies 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
- 31 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
- NCT02142400
- Sponsor's protocol ID
- DS1093-A-E102
- Status last verified
- Apr 2015
- First submitted
- 14 May 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 Double Blind, Randomised, Placebo-controlled, Multiple Ascending-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DS 1093a in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02142400
- Acronym / sponsor ID
- DS1093-A-E102
- Conditions
- Anaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 May 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 ascending single study. It is hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week treatment period and will result in increases in reticulocyte count and haemoglobin concentrations in healthy male volunteers
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-1093 | Experimental | Drug: DS-1093Group 1 will receive 10mg, group 2 will receive 25mg of DS-1093 |
| placebo | Placebo comparator | Drug: placeboplacebo to match DS-1093 dosage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subjects, aged 18-45 years.
- A body mass index (BMI, or Quetelet index) in the range 18.0-30.0
- Willing to use a reliable method of contraception during the trial, and for 4 months afterwards
- 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.
- Willingness to give written consent to participate after reading the information and consent form (ICF), and after having the opportunity to discuss the trial with the Investigator or his delegate.
Key exclusion criteria (21 listed)
- Clinically relevant abnormal medical history, physical findings, electrocardiogram (ECG), or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Presence of acute or chronic illness or history of chronic illness (particularly hypertension, seizures, kidney disease or liver disease, including known or newly discovered Gilbert's syndrome) sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of psychotic mental illness.
- Presence or history of malignant disease, other than basal cell carcinoma that was successfully treated at least 5 years ago.
- Any medical history that, in the opinion of the Investigator, is suggestive of a significant bleeding or coagulation risk.
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-1093DS-1093 in capsules with 2.5mg or 25mg per capsule | Drug | DS-1093 |
| placebomatching placebo capsules to DS-1093 capsules | Drug | placebo |
Primary outcome
blood concentration of DS-1093
Time frame: time of dosing through Day 15
level of DS-1093 will be determined in participants blood from the time of initial dosing through 15 days after.
number of adverse events including type and severity
Time frame: date of randomization through Day 98
number, type and severity of adverse events will be reported during the study from initial randomization through Day 98
11 secondary outcomes
levels of EPO
Time frame: time of dosing through 42 days after dosing
levels of VEGF
Time frame: time of dosing through 42 days after dosing
levels of H25
Time frame: time of dosing through 42 days after dosing
levels of Reticulocytes
Time frame: time of dosing through 42 days after dosing
levels of Haemoglobin
Time frame: time of dosing through 42 days after dosing
levels of Haematocrit
Time frame: time of dosing through 42 days after dosing
levels of Red Blood Cells
Time frame: time of dosing through 42 days after dosing
levels of Serum Iron
Time frame: time of dosing through 42 days after dosing
levels of Transferrin
Time frame: time of dosing through 42 days after dosing
levels of TSAT
Time frame: time of dosing through 42 days after dosing
levels of Ferrin
Time frame: time of dosing through 42 days after dosing
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-1093 in people with Anaemia, 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 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?
blood concentration of DS-1093 (time frame: time of dosing through Day 15). The study lists 2 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.