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

NCT04421885 | Completed Phase 1 FDA Drug

• 1 other identifier: SPR994-105
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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)

• Maximum plasma concentration (Cmax).

  24h (Day 2) post dose (Arms: A, B, C)

Secondary Outcomes (12)

• Time to the maximum plasma concentration (Tmax).

  24h (Day 2) post dose (Arms: A, B, C)

• 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)

• 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

Study Arms (3)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

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

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

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

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

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

B: TBPM-PI-HBr (Test - fasted); C: TBPM-PI-HBr (Test - fed)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spero Therapeutics: lead

Study Sites (1)

Medical Facility

Tempe, Arizona, 85283, United States

Location

Study Officials

• David Melnick

  Spero Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2020
• Primary Completion: July 11, 2020
• Study Completion: July 29, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

US (1)