A Pilot Single Dose Crossover Pharmacokinetics Study Of JDP-205 Injection, 10 mg, In Healthy Male And Female Volunteers
Primary Purpose
Acute Urticaria
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Deep muscle injection
Sub-Q Injection
Sponsored by
About this trial
This is an interventional treatment trial for Acute Urticaria
Eligibility Criteria
Inclusion Criteria:
Volunteers meeting all of the following criteria were considered for enrollment in the study:
- Male or female volunteer
- Volunteer aged of at least 18 years
- Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
- Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
- Availability for the entire study period
- Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination (including the examination of the anterolateral thigh muscles) and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
- Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
Exclusion Criteria:
Volunteers presenting any of the following were not included in the study:
- Females who are pregnant or are lactating
- Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study (from the screening visit until study completion)
- History of significant hypersensitivity to cetirizine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other clinically significant ECG abnormalities
- Known presence of rare hereditary problems of galactose and /or lactose intolerance
- Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
- Use of antihistaminic medication in the previous 7 days before day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive urine screening of ethanol and/or drugs of abuse
- Positive results to HIV, HBsAg or anti-HCV tests
- Females who are pregnant according to a positive serum pregnancy test
- Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Sites / Locations
- Algorithme Pharma
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Injection location1
Injection location 2
Arm Description
Single dose IM injection
Single dose IM Injection
Outcomes
Primary Outcome Measures
Difference in pharmacokinetics: Difference in AUC
Differences in pharmacokinetics: difference in Cmax
Secondary Outcome Measures
Full Information
NCT ID
NCT02045524
First Posted
January 22, 2014
Last Updated
January 23, 2014
Sponsor
JDP Therapeutics, Inc.
Collaborators
Algorithme Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT02045524
Brief Title
A Pilot Single Dose Crossover Pharmacokinetics Study Of JDP-205 Injection, 10 mg, In Healthy Male And Female Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JDP Therapeutics, Inc.
Collaborators
Algorithme Pharma Inc
4. Oversight
5. Study Description
Brief Summary
The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205 injection at 10 mg dose administered by intramuscular injection using various injection techniques in healthy male and female volunteers after a single dose administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection location1
Arm Type
Experimental
Arm Description
Single dose IM injection
Arm Title
Injection location 2
Arm Type
Experimental
Arm Description
Single dose IM Injection
Intervention Type
Other
Intervention Name(s)
Deep muscle injection
Intervention Type
Other
Intervention Name(s)
Sub-Q Injection
Primary Outcome Measure Information:
Title
Difference in pharmacokinetics: Difference in AUC
Time Frame
8 hours post dose
Title
Differences in pharmacokinetics: difference in Cmax
Time Frame
8 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Volunteers meeting all of the following criteria were considered for enrollment in the study:
Male or female volunteer
Volunteer aged of at least 18 years
Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
Availability for the entire study period
Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination (including the examination of the anterolateral thigh muscles) and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
Exclusion Criteria:
Volunteers presenting any of the following were not included in the study:
Females who are pregnant or are lactating
Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study (from the screening visit until study completion)
History of significant hypersensitivity to cetirizine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other clinically significant ECG abnormalities
Known presence of rare hereditary problems of galactose and /or lactose intolerance
Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Any clinically significant illness in the previous 28 days before day 1 of this study
Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
Use of antihistaminic medication in the previous 7 days before day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive urine screening of ethanol and/or drugs of abuse
Positive results to HIV, HBsAg or anti-HCV tests
Females who are pregnant according to a positive serum pregnancy test
Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Facility Information:
Facility Name
Algorithme Pharma
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
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A Pilot Single Dose Crossover Pharmacokinetics Study Of JDP-205 Injection, 10 mg, In Healthy Male And Female Volunteers
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