HealthyPhase 1NCT03612557
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
A Phase 1 study testing penicillin G benzathine in people with Healthy, run by Pfizer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- penicillin G benzathine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 20 Aug 2018to 2 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Japan1 site
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071
About this study
Official 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
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
- Being tested
- penicillin G benzathine
- Keywords
- Benzathine benzylpenicillin, penicillin G benzathine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penicillin G benzathineDrug
Also called penicillin G, benzathine benzylpenicillin
2.4 million units (IM) of benzathine benzylpenicillin
| Study group | Role | What they receive |
|---|---|---|
| active treatment arm | Experimental | penicillin G benzathine treatment Receives: Drug: penicillin G benzathine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration for penicillin G (Cmax)
Measured: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Time to Cmax (Tmax)
Measured: 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)
Measured: 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)
Measured: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent clearance (as data permit) (CL/F)
Measured: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent volume of distribution (as data permit) (Vz/F)
Measured: 0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Terminal half life (as data permit) (t1/2)
Measured: 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
Measured: Screening up to 28 days after last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start20 Aug 2018
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612557
- Sponsor's protocol ID
- B8441001
- Status last verified
- Oct 2018
- First submitted
- 27 Jul 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03612557
- Acronym / sponsor ID
- B8441001
- Conditions
- Healthy
- Keywords
- Benzathine benzylpenicillin, penicillin G benzathine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active treatment arm | Experimental | Drug: penicillin G benzathinepenicillin G benzathine treatment |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| penicillin G benzathineAlso: penicillin G, benzathine benzylpenicillin2.4 million units (IM) of benzathine benzylpenicillin | Drug | active treatment arm |
Primary outcome
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
Time to Cmax (Tmax)
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 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
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 clearance (as data permit) (CL/F)
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
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
1 secondary outcome
Number of Subjects experiencing an Adverse Event
Time frame: Screening up to 28 days after last dose of study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing penicillin G benzathine in people with Healthy, run by Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.