A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: penicillin G benzathine

• Registration Number: NCT03612557
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Study Start: 2018-08-20
• Status Verified: 2018-10
• Primary Completion: 2018-10-02
• Study Completion: 2018-10-02
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active treatment arm	penicillin G benzathine	penicillin G benzathine treatment

Primary Outcome Measures

Name	Time	Method
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
Maximum observed plasma concentration for penicillin G (Cmax)	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 volume of distribution (as data permit) (Vz/F)	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
Apparent clearance (as data permit) (CL/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

Name	Time	Method
Number of Subjects experiencing an Adverse Event	Screening up to 28 days after last dose of study medication

Trial Locations

Locations (1)

P-one Clinic, Keikokai Medical Corporation; 🇯🇵 Hachioji-shi, Tokyo, Japan