Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421885
• Other study ID #: SPR994-105
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2020
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2020
• Source: Spero Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 29, 2020
• Est. primary completion date: July 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference
600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.
• Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.

Locations

Country	Name	City	State
United States	Medical Facility	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Spero Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve extrapolated to infinity (AUC0-8).		24h (Day 2) post dose (Arms: A, B, C)
Primary	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)
Primary	Maximum plasma concentration (Cmax).		24h (Day 2) post dose (Arms: A, B, C)
Secondary	Time to the maximum plasma concentration (Tmax).		24h (Day 2) post dose (Arms: A, B, C)
Secondary	Terminal elimination half-life (t½).		24h (Day 2) post dose (Arms: A, B, C)
Secondary	Apparent total body clearance (CL/F)		24h (Day 2) post dose (Arms: A, B, C)
Secondary	Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).		24h (Day 2) post dose (Arms: A, B, C)
Secondary	Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.	ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs.	12 to 14 days after the last dose of study drug
Secondary	Area under the curve extrapolated to infinity (AUC0-8).	TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.	24h (Day 2) post dose (Arms: B, C)
Secondary	Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).	TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.	24h (Day 2) post dose (Arms: B, C)
Secondary	Maximum plasma concentration (Cmax).	TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.	24h (Day 2) post dose (Arms: B, C)
Secondary	Time to the maximum plasma concentration (Tmax).	TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.	24h (Day 2) post dose (Arms: B, C)
Secondary	Terminal elimination half-life (t½).	TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.	24h (Day 2) post dose (Arms: B, C)
Secondary	Apparent total body clearance (CL/F)	TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.	24h (Day 2) post dose (Arms: B, C)
Secondary	Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).	TPBM PK parameters following administration of the TBPM-PI-HBr Test tablet under fasted and fed conditions.	24h (Day 2) post dose (Arms: B, C)