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Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02024152
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : January 3, 2014
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by (Responsible Party):
JDP Therapeutics, Inc.

Brief Summary:
This study is to investigate the pharmacokinetics (PK) together with the safety and tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in healthy male and female volunteers after a single dose administration.

Condition or disease Intervention/treatment Phase
Acute Urticaria Drug: JDP-205 IV high dose Drug: JDP-205 IV low dose Drug: JDP-205 IM Drug: Control: Zyrtec Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: JDP-205 IV high dose Drug: JDP-205 IV high dose
Drug: JDP-205 IV low dose
Drug: JDP-205 IM
Experimental: JDP-205 IV low dose Drug: JDP-205 IV high dose
Drug: JDP-205 IV low dose
Drug: JDP-205 IM
Experimental: JDP-205 IM high dose Drug: JDP-205 IV high dose
Drug: JDP-205 IV low dose
Drug: JDP-205 IM
Active Comparator: Control Drug: Control: Zyrtec



Primary Outcome Measures :
  1. Difference in pharmacokinetics: Difference in AUC [ Time Frame: 36 hours post dose ]
  2. Differences in pharmacokinetics: difference in Cmax [ Time Frame: 36 hours pose dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female volunteer
  2. Volunteer aged of at least 18 years
  3. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
  4. 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.
  5. Availability for the entire study period
  6. 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
  7. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
  8. 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)
  9. 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:

  1. Females who are pregnant or are lactating
  2. 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)
  3. 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
  4. 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
  5. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
  6. Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  7. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
  8. 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
  9. Known presence of rare hereditary problems of galactose and /or lactose intolerance
  10. 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)
  11. Any clinically significant illness in the previous 28 days before day 1 of this study
  12. 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
  13. Use of antihistaminic medication in the previous 7 days before day 1 of this study
  14. Any history of tuberculosis and/or prophylaxis for tuberculosis
  15. Positive urine screening of ethanol and/or drugs of abuse
  16. Positive results to HIV, HBsAg or anti-HCV tests
  17. Females who are pregnant according to a positive serum pregnancy test
  18. 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
  19. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024152


Locations
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Canada, Quebec
Algorithme Pharma
Montreal, Quebec, Canada
Sponsors and Collaborators
JDP Therapeutics, Inc.
Algorithme Pharma Inc
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Responsible Party: JDP Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02024152    
Other Study ID Numbers: ETTAU-01 (CTN-P0-741)
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs