- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517372
Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast
An Open-label, Single Center, Phase I, Dose Escalation Study Investigating the Safety, Tolerability and Pharmacokinetics of Pemirolast in Healthy Subjects
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent, healthy subjects aged 19-65 years
Exclusion Criteria:
- Significant concurrent disease or medical conditions that are deemed to interfere with the safety or pharmacokinetics of CRD007 conduct of the trial
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cohorte 1
"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
|
Other Names:
|
Active Comparator: Cohorte 2
"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
|
Other Names:
|
Active Comparator: Cohorte 3
"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
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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)
|
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)
|
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)
|
Change from baseline to day 5 (2 hours post dose)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Blood sampling day 1 up to 24 hrs post dose and day 5 up to 24 hrs post dose
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSPR-PE-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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