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Completed

NCT Number: NCT02517372

Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast

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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRD007

Drug

Other names: Pemirolast

Primary outcomes

  1. 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)

  2. 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)

  3. ECG recording as a measure of Safety and Tolerability

    Time frame: Change from baseline to day 5 (12 hours post dose)

  4. 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)

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))

    Time frame: Blood sampling day 1 up to 24 hrs post dose and day 5 up to 24 hrs post dose

Sponsors and collaborators

Lead sponsor

RSPR Pharma AB

Industry

Registry information

Official study title

An Open-label, Single Center, Phase I, Dose Escalation Study Investigating the Safety, Tolerability and Pharmacokinetics of Pemirolast in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2015
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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