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Completed

NCT Number: NCT03612557

A Study of Benzathine Benzylpenicillin Intramuscular Injection 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.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, 192-0071, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Penicillin G Benzathine

Drug

2.4 million units (IM) of benzathine benzylpenicillin

Other names: penicillin G, benzathine benzylpenicillin

Primary outcomes

  1. Maximum observed plasma concentration for penicillin G (Cmax)

    Time frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

  2. Time to Cmax (Tmax)

    Time frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

  3. Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)

    Time frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

  4. Area under the plasma concentration time curve from time zero extrapolated to infinite time (as data permit)(AUCinf)

    Time frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

  5. Apparent clearance (as data permit) (CL/F)

    Time frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

  6. Apparent volume of distribution (as data permit) (Vz/F)

    Time frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

  7. Terminal half life (as data permit) (t1/2)

    Time frame: 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

    Time frame: Screening up to 28 days after last dose of study medication

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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