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

NCT ID: NCT04421885

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-07-29

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.

Interventions

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

600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.

Intervention Type: DRUG

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

600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Melnick

Role: STUDY_DIRECTOR

Spero Therapeutics

Locations

Medical Facility

Tempe, Arizona, United States

Countries

United States

Other Identifiers

SPR994-105

Identifier Type: -

Identifier Source: org_study_id