A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: penicillin G benzathine

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Hachioji-shi, Tokyo, Japan, 192-0071
      • P-one clinic, Keikokai medical corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active treatment arm; penicillin G benzathine treatment	Drug: penicillin G benzathine; 2.4 million units (IM) of benzathine benzylpenicillin; Other Names: penicillin G; benzathine benzylpenicillin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): October 2, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Benzathine benzylpenicillin; penicillin G benzathine
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Penicillins; Penicillin G Benzathine; Penicillin G; Penicillin G Procaine
• Other Study ID Numbers: B8441001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes