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NCT03612557 Clinical Trial

A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03612557
Other study ID # B8441001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 20, 2018
Est. completion date October 2, 2018

Study information
Verified date October 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date October 2, 2018
Est. primary completion date October 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• penicillin G benzathine
2.4 million units (IM) of benzathine benzylpenicillin

Locations
Country Name City State
Japan P-one Clinic, Keikokai Medical Corporation Hachioji-shi Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum observed plasma concentration for penicillin G (Cmax) 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Primary Time to Cmax (Tmax) 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Primary 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
Primary 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
Primary Apparent clearance (as data permit) (CL/F) 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Primary Apparent volume of distribution (as data permit) (Vz/F) 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Primary Terminal half life (as data permit) (t1/2) 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Secondary Number of Subjects experiencing an Adverse Event Screening up to 28 days after last dose of study medication
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