First-In-Human PainCart Study for STR-324

December 11, 2018 updated by: Stragen France

A First-in-Human, Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STR-324 in Healthy Subjects

This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure
  • Healthy male subjects, 18 to 45 years of age, inclusive at screening.
  • Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
  • All males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.
  • Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria:

  • Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
  • Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters
  • Abnormal renal function (eGFR (MDRD) < 60 mL/min/1.73m2).
  • Previous history of seizures or epilepsy.
  • Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day.
  • Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies, Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
  • Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer).
  • Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
  • Participation in an investigational drug or device study within 3 months prior to first dosing.
  • History of abuse of addictive substances or current use of substances (alcohol, illegal substances)
  • Positive test for drugs of abuse or alcohol breath test at screening or pre-dose.
  • Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
  • Loss or donation of blood over 500 mL within three months prior to screening
  • Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold or pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug: Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: STR-324 Dose Level 1
Short infusion of a solution for intravenous administration
Drug: STR-324 Dose Level 3
Short infusion of a solution for intravenous administration
Drug: STR-324 Dose Level 5
Short infusion of a solution for intravenous administration
Drug: STR-324 Dose Level 7
Short infusion of a solution for intravenous administration
Drug: Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Experimental: Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug: Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: STR-324 Dose Level 2
Short infusion of a solution for intravenous administration
Drug: STR-324 Dose Level 4
Short infusion of a solution for intravenous administration
Drug: STR-324 Dose Level 6
Short infusion of a solution for intravenous administration
Drug: STR-324 Dose Level 8
Short infusion of a solution for intravenous administration
Experimental: Part II (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization.
Drug: Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: STR-324 Dose Level A
Long infusion of a solution for intravenous administration
Experimental: Part II (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization.
Drug: Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: STR-324 Dose Level B
Long infusion of a solution for intravenous administration
Experimental: Part II (Panel 3): STR-324 or placebo
Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.
Drug: Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Drug: STR-324 Dose Level C
Long infusion of a solution for intravenous administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety and tolerability: number of subjects who experience (serious) treatment emergent adverse events, potential clinically changes in vital signs, ECG, holter, physical examinations, laboratory tests and urine production
Time Frame: Day 7 (+/- 2 days) post dosing
Day 7 (+/- 2 days) post dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Parts I and II: Maximum plasma concentration (Cmax)
Time Frame: Up to 24 hours for Part I and up to 52 hours for Part II
Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II:Time to maximum plasma concentration (Tmax)
Time Frame: Up to 24 hours for Part I and up to 52 hours for Part II
Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Area under the plasma concentration-time curve from zero to infinity(AUC0-inf)
Time Frame: Up to 24 hours for Part I and up to 52 hours for Part II
Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Area under the plasma concentration-time curve from zero to the last measured concentration above the limit of quantification (AUC0-last)
Time Frame: Up to 24 hours for Part I and up to 52 hours for Part II
Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Terminal disposition rate constant (λz) with the respective half-life (t½)
Time Frame: Up to 24 hours for Part I and up to 52 hours for Part II
Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Amount excreted in urine in 24 hours
Time Frame: Up to 24 hours for Part I and up to 72 hours for Part II
Up to 24 hours for Part I and up to 72 hours for Part II
Parts I and II: Thermal Pain
Time Frame: Up to 5 hours for part I and up to 56 hours for part II
Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Electrical pain Stair and Burst
Time Frame: Up to 5 hours for part I and up to 56 hours for part II
Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Pressure Pain
Time Frame: Up to 5 hours for part I and up to 56 hours for part II
Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Cold Pressor
Time Frame: Up to 5 hours for part I and up to 56 hours for part II
Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor)
Time Frame: Up to 5 hours for part I and up to 56 hours for part II
Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Visual Analogue Scale Bond & Lader
Time Frame: Up to 5 hours for part I and up to 56 hours for part II
Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Visual Analogue Scale Bowdle
Time Frame: Up to 5 hours for part I and up to 56 hours for part II
Up to 5 hours for part I and up to 56 hours for part II
Part II only: Saccadic eye movement
Time Frame: Up to 56 hours
Up to 56 hours
Part II only: Smooth pursuit eye movement
Time Frame: Up to 56 hours
Up to 56 hours
Part II only: Adaptive tracking
Time Frame: Up to 56 hours
Up to 56 hours
Part II only: Body sway
Time Frame: Up to 56 hours
Up to 56 hours
Part II only: N-Back
Time Frame: Up to 56 hours
Up to 56 hours
Part II only: Pharmaco-EEG: power
Time Frame: Up to 56 hours
Up to 56 hours
Part II only: Pupillometry
Time Frame: Up to 56 hours
Up to 56 hours
Part II only: 49-item Addiction Center Research Inventory
Time Frame: Up to 60 hours
Up to 60 hours
Part II only: Bowel Function Index
Time Frame: Up to day 7
Up to day 7
Part II - Groups 2 and 3 only: Thermal pain (Normal skin and erythema skin - UVB)
Time Frame: Up to 24 hours
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stragen France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STR-324-CL-039
  • 2014-002402-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Locations

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