A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

NCT03612557 | Completed Phase 1 FDA Drug

• 1 other identifier: B8441001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Benzathine benzylpenicillin; penicillin G benzathine

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Number of Subjects experiencing an Adverse Event

  Screening up to 28 days after last dose of study medication

Study Arms (1)

active treatment arm

EXPERIMENTAL

penicillin G benzathine treatment

Drug: penicillin G benzathine

Interventions

penicillin G benzathine DRUG

2.4 million units (IM) of benzathine benzylpenicillin

Also known as: penicillin G, benzathine benzylpenicillin

active treatment arm

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, 192-0071, Japan

Location

Related 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.

MeSH Terms

Interventions

Penicillin G Benzathine; Penicillin G

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: August 20, 2018
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)