Healthy VolunteersPhase 1NCT02517372
Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast
A Phase 1 study testing CRD007 in people with Healthy Volunteers, run by RSPR Pharma AB.
Trial summary
This study is a single-centre, open-label, dose escalation , safety, tolerability and pharmacokinetics (PK) study in healthy male and female subjects. The study include a screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and each cohort will include 8 subjects. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CRD007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent, healthy subjects aged 19-65 years
Who cannot join
- Significant concurrent disease or medical conditions that are deemed to interfere with the safety or pharmacokinetics of CRD007 conduct of the trial
About this study
Official title: An Open-label, Single Center, Phase I, Dose Escalation Study Investigating the Safety, Tolerability and Pharmacokinetics of Pemirolast in Healthy Subjects
This study is a single-centre, open-label, dose escalation , safety, tolerability and pharmacokinetics (PK) study in healthy male and female subjects. The study include a screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and each cohort will include 8 subjects. there will be 24 subjects total included in the study. The duration of the clinical part of the study will be approximately 2 months.
Read the detailed description
Subjects meeting the eligibility criteria at screening will remain in the clinic from the evening preceding the first day of dosing (Day - 1) of the investigational medical product (IMP) and check out from the clinic 24 hours after the first dose administration of the IMP (in the morning of Day 2). Dose administration of the IMP in the evening of Day 2 and morning and evening dose for Days 3 and 4 will be performed at home. The subjects will check-in again in the morning of Day 5 and receive the last dose administration of the IMP and stay in the clinic 12 hours post dose. All subjects within the same cohort will receive the same dose of the IMP.
There will be 3 cohorts (dose-levels) with 8 subjects in each cohort corresponding to 24 subjects in total. Within a cohort the subjects will be dosed in groups of 4. There will be 24 hours between the dosing of the groups and 15 minutes between the dosing of the subjects in a group.
There will be an interval of approximately at least 1-week interval between the cohorts to allow time for compilation and evaluation of data for the Internal Safety Review Committee meeting.
Subsequent cohorts will be administered increasing doses until either the maximum tolerated dose (MTD) or the study maximum dose (SMD) has been reached.
- Conditions
- Healthy Volunteers
- Being tested
- CRD007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD007Drug
Also called Pemirolast
| Study group | Role | What they receive |
|---|---|---|
| Cohorte 1 | Active comparator | "Low dose" pemirolast sodium (CRD007) given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day Receives: Drug: CRD007 |
| Cohorte 2 | Active comparator | "Medium dose" CRD007 given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day Receives: Drug: CRD007 |
| Cohorte 3 | Active comparator | "High dose" CRD007 given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day Receives: Drug: CRD007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Events as a measure of Safety and Tolerability
Measured: Change from baseline to day 5 (12 hours post dose)
Results of physical examination as a composite outcome measure of Safety and Tolerability
Measured: Change from baseline to day 5 (12 hours post dose)
ECG recording as a measure of Safety and Tolerability
Measured: Change from baseline to day 5 (12 hours post dose)
Vital signs (Blood Pressure and Pulse Rate) as a composite outcome measure of Safety and Tolerability
Measured: Change from baseline to day 5 (2 hours post dose)
Secondary outcomes (1)
Composite outcome measure consisting of multiple pharmacokinetics measures (Area Under the plasma concentration-time Curve (AUC), Plasma elimination half-life (t½), Time to maximum plasma drug concentration (Tmax), and Peak Plasma Concentration (Cmax))
Measured: Blood sampling day 1 up to 24 hrs post dose and day 5 up to 24 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSPR Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517372
- Sponsor's protocol ID
- RSPR-PE-006
- Status last verified
- Aug 2015
- First submitted
- 29 Apr 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Center, Phase I, Dose Escalation Study Investigating the Safety, Tolerability and Pharmacokinetics of Pemirolast in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02517372
- Acronym / sponsor ID
- RSPR-PE-006
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- RSPR Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Aug 2015 (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 study is a single-centre, open-label, dose escalation , safety, tolerability and pharmacokinetics (PK) study in healthy male and female subjects. The study include a screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and each cohort will include 8 subjects. there will be 24 subjects total included in the study. The duration of the clinical part of the study will be approximately 2 months.
Detailed description
Subjects meeting the eligibility criteria at screening will remain in the clinic from the evening preceding the first day of dosing (Day - 1) of the investigational medical product (IMP) and check out from the clinic 24 hours after the first dose administration of the IMP (in the morning of Day 2). Dose administration of the IMP in the evening of Day 2 and morning and evening dose for Days 3 and 4 will be performed at home. The subjects will check-in again in the morning of Day 5 and receive the last dose administration of the IMP and stay in the clinic 12 hours post dose. All subjects within the same cohort will receive the same dose of the IMP.
There will be 3 cohorts (dose-levels) with 8 subjects in each cohort corresponding to 24 subjects in total. Within a cohort the subjects will be dosed in groups of 4. There will be 24 hours between the dosing of the groups and 15 minutes between the dosing of the subjects in a group.
There will be an interval of approximately at least 1-week interval between the cohorts to allow time for compilation and evaluation of data for the Internal Safety Review Committee meeting.
Subsequent cohorts will be administered increasing doses until either the maximum tolerated dose (MTD) or the study maximum dose (SMD) has been reached.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohorte 1 | Active comparator | Drug: CRD007"Low dose" pemirolast sodium (CRD007) given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day |
| Cohorte 2 | Active comparator | Drug: CRD007"Medium dose" CRD007 given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day |
| Cohorte 3 | Active comparator | Drug: CRD007"High dose" CRD007 given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent, healthy subjects aged 19-65 years
Key exclusion criteria (1 listed)
- Significant concurrent disease or medical conditions that are deemed to interfere with the safety or pharmacokinetics of CRD007 conduct of the trial
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 |
|---|---|---|
| CRD007Also: Pemirolast | Drug | Cohorte 1, Cohorte 2, Cohorte 3 |
Primary outcome
Number of patients with Adverse Events as a measure of Safety and Tolerability
Time frame: Change from baseline to day 5 (12 hours post dose)
Results of physical examination as a composite outcome measure of Safety and Tolerability
Time frame: Change from baseline to day 5 (12 hours post dose)
ECG recording as a measure of Safety and Tolerability
Time frame: Change from baseline to day 5 (12 hours post dose)
Vital signs (Blood Pressure and Pulse Rate) as a composite outcome measure of Safety and Tolerability
Time frame: Change from baseline to day 5 (2 hours post dose)
1 secondary outcome
Composite outcome measure consisting of multiple pharmacokinetics measures (Area Under the plasma concentration-time Curve (AUC), Plasma elimination half-life (t½), Time to maximum plasma drug concentration (Tmax), and Peak Plasma Concentration (Cmax))
Time frame: Blood sampling day 1 up to 24 hrs post dose and day 5 up to 24 hrs post dose
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 7 Aug 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRD007 in people with Healthy Volunteers, run by RSPR Pharma AB.
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 1 inclusion and 1 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with Adverse Events as a measure of Safety and Tolerability (time frame: Change from baseline to day 5 (12 hours post dose)). The study lists 4 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 7 Aug 2015.