Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - TestDrug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference
- Registration Number
- NCT04421885
- Lead Sponsor
- Spero Therapeutics
- Brief Summary
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B: TBPM-PI-HBr (Test - fasted) Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test 600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions. A: TBPM-PI-HBr (Reference - fasted) Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference 600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions. C: TBPM-PI-HBr (Test - fed) Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test 600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fed conditions.
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax). 24h (Day 2) post dose (Arms: A, B, C) Area under the curve extrapolated to infinity (AUC0-∞). 24h (Day 2) post dose (Arms: A, B, C) Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t). 24h (Day 2) post dose (Arms: A, B, C)
- Secondary Outcome Measures
Name Time Method Time to the maximum plasma concentration (Tmax). 24h (Day 2) post dose (Arms: B, C) TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Maximum plasma concentration (Cmax). 24h (Day 2) post dose (Arms: B, C) TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Terminal elimination half-life (t½). 24h (Day 2) post dose (Arms: B, C) TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Apparent total body clearance (CL/F) 24h (Day 2) post dose (Arms: B, C) TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F). 24h (Day 2) post dose (Arms: B, C) TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug. 12 to 14 days after the last dose of study drug ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.
Area under the curve extrapolated to infinity (AUC0-∞). 24h (Day 2) post dose (Arms: B, C) TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t). 24h (Day 2) post dose (Arms: B, C) TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.
Trial Locations
- Locations (1)
Medical Facility
🇺🇸Tempe, Arizona, United States