A Pilot Single Dose Crossover Pharmacokinetics Study Of JDP-205 Injection, 10 mg, In Healthy Male And Female Volunteers

NCT02045524 | Completed Phase 1

• 1 other identifier: ETTAU-01P (CTN-P1-571)
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Urticaria

Outcome Measures

Primary Outcomes (2)

• Difference in pharmacokinetics: Difference in AUC

  8 hours post dose

• Differences in pharmacokinetics: difference in Cmax

  8 hours post dose

Study Arms (2)

Injection location1

EXPERIMENTAL

Single dose IM injection

Other: Deep muscle injection

Injection location 2

EXPERIMENTAL

Single dose IM Injection

Other: Sub-Q Injection

Interventions

Deep muscle injection OTHER

Injection location1

Sub-Q Injection OTHER

Injection location 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JDP Therapeutics, Inc.: lead
• Algorithme Pharma Inc: collaborator

Study Sites (1)

Algorithme Pharma

Montreal, Quebec, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CA (1)