A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- penicillin G benzathine
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
active treatment arm
penicillin G benzathine treatment
Intervention: penicillin G benzathine
Outcomes
Primary Outcomes
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
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
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
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
Time to Cmax (Tmax)
Time Frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent clearance (as data permit) (CL/F)
Time Frame: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
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
- Number of Subjects experiencing an Adverse Event(Screening up to 28 days after last dose of study medication)