Clareo Health | Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spero Therapeutics
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.
Continuous non-smoker
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
You may not be if
Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected to have during the conduct of the study.
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
History of significant allergic disease requiring treatment
History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.
History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (especially fluoroquinolone-, carbapenem-, penicillin-, and cephalosporin-antibiotics sensitivity).
History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia).
History of cholecystectomy.
Female subjects with a positive pregnancy test at the screening visit or first check-in or who are lactating.
Positive urine drug or alcohol results at the screening visit or first check-in.
Positive results at the screening visit for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
