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
1 other identifier
interventional
24
0 countries
N/A
Brief 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. there will be 24 subjects total included in the study. The duration of the clinical part of the study will be approximately 2 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Oct 2014
Shorter than P25 for phase_1 healthy-volunteers
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
August 7, 2015
CompletedAugust 7, 2015
August 1, 2015
2 months
April 29, 2015
August 4, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Number of patients with Adverse Events as a measure of Safety and Tolerability
Change from baseline to day 5 (12 hours post dose)
Results of physical examination as a composite outcome measure of Safety and Tolerability
Change from baseline to day 5 (12 hours post dose)
ECG recording as a measure of Safety and Tolerability
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
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))
Blood sampling day 1 up to 24 hrs post dose and day 5 up to 24 hrs post dose
Study Arms (3)
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
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
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
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent, healthy subjects aged 19-65 years
You may not qualify if:
- Significant concurrent disease or medical conditions that are deemed to interfere with the safety or pharmacokinetics of CRD007 conduct of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RSPR Pharma ABlead
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2015
First Posted
August 7, 2015
Study Start
October 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 7, 2015
Record last verified: 2015-08