Clareo Health | A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants
A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spero Therapeutics
With
GlaxoSmithKline
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
Body weight considering body mass index (BMI) within the range of 18 to 32 kilogram per meter square (kg/m\^2), inclusive.
Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 55 years of age inclusive, at the time of signing the informed consent.
You may not be if
History or presence of/significant history of or current cardiovascular (CV), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or study procedures or interfering with the interpretation of data.
Past or intended use of over-the-counter or prescription medication including herbal medications within 28 days prior to dosing, with the exception of supplemental vitamins, hormonal medications (contraceptives or hormone-replacement therapy), or occasional oral acetaminophen (not to exceeding 2 g total daily dose).
Current enrollment or past participation in another investigational/observational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days, or 5 half-lives whichever is longer.
Positive COVID-19 screening test using PCR or antigen assay at Day -1
Donation of, or significant blood loss of, more than 500 mL of blood within 56 days prior to dosing.
Receipt of a blood transfusion within 1 year prior to enrollment or plasma donation within 7 days prior to dosing.
