ThrombosisPhase 1NCT03903302
Study Investigation Pharmacokinetics and Pharmacodynamics of CS1
A Phase 1 study testing CS1-Sodium Valproate in people with Thrombosis, run by Cereno Scientific AB at 1 site in Sweden.
Trial summary
SAD study: Eighteen subjects will be included in the SAD study (single dose) in 3 parallel arms, each with 6 subjects. The 3 arms will receive a single dose of one of the CS1 formulations I, II or III. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- CS1-Sodium Valproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 6 Oct 2017to 27 Mar 2018
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study
- Male and female subjects age ≥ 40 years, ≤ 75 years inclusive.
- BMI 27- 35 kg/m2
- PAI-1 levels minimum 15 kIE/L (applies only to the MAD study)
- Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. Subjects with stable hypertension with one or more antihypertensive drugs can be accepted as acceptable medical history.
- Male subjects who has not documented a vasectomy, must be willing to use condom from the date of dosing until three months after dosing of the IMP to prevent drug exposure of a partner and refrain from donating sperm and if they have a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy .
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- The females must be of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of amenorrhea (simultaneous determination of follicle stimulating hormone 25-140 IU/l and estradiol < 200 pmol/l is confirmatory) -
- Willing and able to give written informed consent for participation in the study
- Male and female subjects age ≥ 40 years, ≤ 75 years inclusive.
- BMI 27- 35 kg/m2
- PAI-1 levels minimum 15 kIE/L (applies only to the MAD study)
- Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. Subjects with stable hypertension with one or more antihypertensive drugs can be accepted as acceptable medical history.
- Male subjects who has not documented a vasectomy, must be willing to use condom from the date of dosing until three months after dosing of the IMP to prevent drug exposure of a partner and refrain from donating sperm and if they have a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy .
- The females must be of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of amenorrhea (simultaneous determination of follicle stimulating hormone 25-140 IU/l and estradiol < 200 pmol/l is confirmatory)
Who cannot join
- Diagnosis and main eligibility criteria
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Subjects with active or chronic liver disease or personal or familiar history of drug related severe hepatic dysfunction.
- Subjects with phorphyria.
- Subjects with Systemic lupus erytematosus (SLE)
- Subjects with TPK, APTT, INR levels which are significant outside the reference intervals as judged by the investigator.
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- History of severe bleeding disease or thrombotic disease.
- Subjects on regular treatment with anticoagulant or antiplatelets drugs
- Subjects with significant cardiac disease.
- Subjects with significant pancreatic disease.
- Subjects with gastrointestinal problems/ diseases e.g. inflammatory bowel disease and irritable bowel syndrome
- Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
- Any planned major surgery within the duration of the study.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
- After 10 minute supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure > 160 mm Hg
- Diastolic blood pressure > 100 mm Hg
- Heart rate < 40 or > 90 beats per minute
- Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to valproate acid or any other ingredient of the investigational medicinal product.
- Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study. Subjects consented and screened but not dosed in previous phase I studies are not excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
- Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IMP.
- Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.
- Intake of xanthine and/or taurine containing energy drinks within two days prior to screening.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomised Study to Investigate Pharmacokinetics of CS1, Safety and Tolerability and in Obese, Borderline Hypertensive But Otherwise Healthy and Medicine Free Subjects After Administration of Single and Multiple Doses
SAD study:
Eighteen subjects will be included in the SAD study (single dose) in 3 parallel arms, each with 6 subjects. The 3 arms will receive a single dose of one of the CS1 formulations I, II or III. The result of the pharmacokinetics analysis from the 6 first subjects is defined as SAD Pilot and will be used to evaluate the timing of PK sampling. Based on pharmacokinetic evaluations from all 18 subjects one of the formulations I (275 mg), II (276 mg) or III (276 mg) will be chosen to proceed into the MAD study. If none of the formulations show the desired PK properties the formulations may be re-dosed with a slightly different timing of the dose, i.e the IMP to be administered earlier or later during the evening.
Read more
MAD study:
Fifteen subjects will be included in a dose escalating study with 2 dose levels. The subjects will receive the lowest dose level (275 or 276 mg depending on the outcome of SAD) for the first 2 weeks before the dose is doubled (550 or 552 mg depending on the outcome of SAD) for the following 2 weeks.
- Conditions
- Thrombosis
- Being tested
- CS1-Sodium Valproate
- Keywords
- tissue-plasminogen activator (t-PA), plasminogen-activator inhibitor 1 (PAI-1), fibrinolysis, thrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1-Sodium ValproateDrug
Single and multiple dose evaluation of CS1
| Study group | Role | What they receive |
|---|---|---|
| CS 1 I SAD | Active comparator | Single dose pharmacokinetics of CS1 I Receives: Drug: CS1-Sodium Valproate |
| CS 1 II SAD | Active comparator | Single dose pharmacokinetics of CS1 II Receives: Drug: CS1-Sodium Valproate |
| CS 1 III SAD | Active comparator | Single dose pharmacokinetics of CS1 III Receives: Drug: CS1-Sodium Valproate |
| CS 1 II MAD | Active comparator | Multiple dose pharmacokinetics of CS1 II Receives: Drug: CS1-Sodium Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic of CS1 in plasma
Plasma concentration of Valproate in plasma
Measured: up to four weeks
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Adverse event recording in free text
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start6 Oct 2017
- Primary completion28 Feb 2018
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Safety, pharmacokinetics and pharmacodynamics of CS1
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cereno Scientific AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jan Erik Berglund, Cereno Scientific AB
- Investigators
- Niklas Bergh, PhD, Study chair, Cereno Scientific AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903302
- Sponsor's protocol ID
- CS1-001
- Other IDs
- 2017-002140-32, 2017
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomised Study to Investigate Pharmacokinetics of CS1, Safety and Tolerability and in Obese, Borderline Hypertensive But Otherwise Healthy and Medicine Free Subjects After Administration of Single and Multiple Doses
- ClinicalTrials.gov ID
- NCT03903302
- Acronym / sponsor ID
- CS1-001
- Conditions
- Thrombosis
- Keywords
- tissue-plasminogen activator (t-PA), plasminogen-activator inhibitor 1 (PAI-1), fibrinolysis, thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cereno Scientific ABIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 4 Apr 2019 (actual)
- 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.
SAD study:
Eighteen subjects will be included in the SAD study (single dose) in 3 parallel arms, each with 6 subjects. The 3 arms will receive a single dose of one of the CS1 formulations I, II or III. The result of the pharmacokinetics analysis from the 6 first subjects is defined as SAD Pilot and will be used to evaluate the timing of PK sampling. Based on pharmacokinetic evaluations from all 18 subjects one of the formulations I (275 mg), II (276 mg) or III (276 mg) will be chosen to proceed into the MAD study. If none of the formulations show the desired PK properties the formulations may be re-dosed with a slightly different timing of the dose, i.e the IMP to be administered earlier or later during the evening.
MAD study:
Fifteen subjects will be included in a dose escalating study with 2 dose levels. The subjects will receive the lowest dose level (275 or 276 mg depending on the outcome of SAD) for the first 2 weeks before the dose is doubled (550 or 552 mg depending on the outcome of SAD) for the following 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Safety, pharmacokinetics and pharmacodynamics of CS1
| Arm | Type | Receives |
|---|---|---|
| CS 1 I SAD | Active comparator | Drug: CS1-Sodium ValproateSingle dose pharmacokinetics of CS1 I |
| CS 1 II SAD | Active comparator | Drug: CS1-Sodium ValproateSingle dose pharmacokinetics of CS1 II |
| CS 1 III SAD | Active comparator | Drug: CS1-Sodium ValproateSingle dose pharmacokinetics of CS1 III |
| CS 1 II MAD | Active comparator | Drug: CS1-Sodium ValproateMultiple dose pharmacokinetics of CS1 II |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to give written informed consent for participation in the study
- Male and female subjects age ≥ 40 years, ≤ 75 years inclusive.
- BMI 27- 35 kg/m2
- PAI-1 levels minimum 15 kIE/L (applies only to the MAD study)
- Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. Subjects with stable hypertension with one or more antihypertensive drugs can be accepted as acceptable medical history.
Key exclusion criteria (28 listed)
- Diagnosis and main eligibility criteria
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Subjects with active or chronic liver disease or personal or familiar history of drug related severe hepatic dysfunction.
- Subjects with phorphyria.
- Subjects with Systemic lupus erytematosus (SLE)
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 |
|---|---|---|
| CS1-Sodium ValproateSingle and multiple dose evaluation of CS1 | Drug | CS 1 I SAD, CS 1 II MAD, CS 1 II SAD, CS 1 III SAD |
Primary outcome
Pharmacokinetic of CS1 in plasma
Time frame: up to four weeks
Plasma concentration of Valproate in plasma
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: up to four weeks
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 8 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Niklas Bergh, PhD study chair
Cereno Scientific AB
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 CS1-Sodium Valproate in people with Thrombosis, run by Cereno Scientific AB at 1 site in Sweden.
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 14 inclusion and 28 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 8 Apr 2019. 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 Sweden. 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?
Pharmacokinetic of CS1 in plasma (time frame: up to four weeks). 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 8 Apr 2019.