Status:
COMPLETED
Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Lead Sponsor:
Spero Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
Eligibility Criteria
Inclusion
- Healthy, adult, male or female, 18 to 55 years of age
- Continuous non-smoker.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs.
- Has suitable venous access for repeated blood sampling.
- A female of childbearing potential must agree to abstain from sexual activity that could lead to pregnancy.
- A female of non-childbearing potential.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Exclusion
- 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.
- History of any illness that 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.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- History of known genetic metabolism anomaly associated with carnitine deficiency.
- Female subjects with a positive pregnancy test or who are lactating.
- Positive urine drug or alcohol results.
- Positive results for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- QTcF interval is \> 460 msec (males) or \> 470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at the screening visit.
- Estimated creatinine clearance \< 80 mL/min at the screening visit.
- Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04421885
Start Date
June 1 2020
End Date
July 29 2020
Last Update
August 12 2020
Active Locations (1)
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1
Medical Facility
Tempe, Arizona, United States, 85283