A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Study Overview
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Brief Summary
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This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.

Official Title
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A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: penicillin G benzathine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg and <100 kg. Exclusion Criteria: • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active treatment arm<br>penicillin G benzathine treatment | Drug: penicillin G benzathine<br>* 2.4 million units (IM) of benzathine benzylpenicillin<br>* Other names: benzathine benzylpenicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration for penicillin G (Cmax) |  | 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose | 
| Time to Cmax (Tmax) |  | 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose | 
| Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast) |  | 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose | 
| Area under the plasma concentration time curve from time zero extrapolated to infinite time (as data permit)(AUCinf) |  | 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose | 
| Apparent clearance (as data permit) (CL/F) |  | 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose | 
| Apparent volume of distribution (as data permit) (Vz/F) |  | 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose | 
| Terminal half life (as data permit) (t1/2) |  | 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects experiencing an Adverse Event |  | Screening up to 28 days after last dose of study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benzathine benzylpenicillin, penicillin G benzathine