Clinical trial NCT04421885: Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Official title: An Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover, Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Spero Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover
Primary purpose: OTHER

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 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.

Primary outcomes:
measure: Area under the curve extrapolated to infinity (AUC0-∞).
timeFrame: 24h (Day 2) post dose (Arms: A, B, C)
measure: Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
timeFrame: 24h (Day 2) post dose (Arms: A, B, C)
measure: Maximum plasma concentration (Cmax).
timeFrame: 24h (Day 2) post dose (Arms: A, B, C)
Secondary outcomes:
measure: Time to the maximum plasma concentration (Tmax).
timeFrame: 24h (Day 2) post dose (Arms: A, B, C)
measure: Terminal elimination half-life (t½).
timeFrame: 24h (Day 2) post dose (Arms: A, B, C)
measure: Apparent total body clearance (CL/F)
timeFrame: 24h (Day 2) post dose (Arms: A, B, C)
measure: Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
timeFrame: 24h (Day 2) post dose (Arms: A, B, C)
measure: Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.
timeFrame: 12 to 14 days after the last dose of study drug
measure: Area under the curve extrapolated to infinity (AUC0-∞).
timeFrame: 24h (Day 2) post dose (Arms: B, C)
measure: Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
timeFrame: 24h (Day 2) post dose (Arms: B, C)
measure: Maximum plasma concentration (Cmax).
timeFrame: 24h (Day 2) post dose (Arms: B, C)
measure: Time to the maximum plasma concentration (Tmax).
timeFrame: 24h (Day 2) post dose (Arms: B, C)
measure: Terminal elimination half-life (t½).
timeFrame: 24h (Day 2) post dose (Arms: B, C)
measure: Apparent total body clearance (CL/F)
timeFrame: 24h (Day 2) post dose (Arms: B, C)
measure: Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
timeFrame: 24h (Day 2) post dose (Arms: B, C)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Medical Facility
state: Arizona
Study officials:
affiliation: Spero Therapeutics
name: David Melnick
role: STUDY_DIRECTOR
References: