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

Spero Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference; Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT04421885

SPR994-105

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

A: TBPM-PI-HBr (Reference - fasted)

Experimental group

Description:

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.

Treatment:

Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference

B: TBPM-PI-HBr (Test - fasted)

Experimental group

Description:

600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fasted conditions.

Treatment:

Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test

C: TBPM-PI-HBr (Test - fed)

Experimental group

Description:

600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr administered at Hour 0 on Day 1, under fed conditions.

Treatment:

Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test