Tebipenem for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any over-the-counter or prescription medications, including herbal medications, at least 28 days before the trial starts, except for vitamins, hormonal medications, or occasional acetaminophen.
Is Tebipenem safe for healthy humans?
What data supports the effectiveness of the drug Tebipenem pivoxil hydrobromide?
Tebipenem pivoxil hydrobromide is an oral drug that has shown effectiveness against multidrug-resistant bacterial infections, similar to intravenous carbapenems like meropenem. It is being developed for treating complicated urinary tract infections and has demonstrated comparable activity to other carbapenems in both laboratory and animal studies.12467
Are You a Good Fit for This Trial?
This trial is for healthy individuals who want to participate in a study assessing the behavior of a drug called Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and its major metabolite in the body. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TBP-PI-HBr in different dosing regimens to assess pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tebipenem-Pivoxil-Hydrobromide
Tebipenem-Pivoxil-Hydrobromide is already approved in Japan for the following indications:
- Paediatric infections limited to pneumonia, otitis media and sinusitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spero Therapeutics
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School