Healthy Volunteers
Conditions
Brief summary
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
Interventions
DRUGTebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference
600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.
DRUGTebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.
Sponsors
Spero Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F). | 24h (Day 2) post dose (Arms: A, B, C) | — |
| 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. |
| Time to the maximum plasma concentration (Tmax). | 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: 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. |
| 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. |
| Terminal elimination half-life (t½). | 24h (Day 2) post dose (Arms: A, B, C) | — |
| Apparent total body clearance (CL/F) | 24h (Day 2) post dose (Arms: A, B, C) | — |
Countries
United States
Outcome results
None listed