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

August 10, 2020 updated by: Spero Therapeutics

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Medical facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference
600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.
Experimental: 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.
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.
Experimental: 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.
Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the curve extrapolated to infinity (AUC0-∞).
Time Frame: 24h (Day 2) post dose (Arms: A, B, C)
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).
Time Frame: 24h (Day 2) post dose (Arms: A, B, C)
24h (Day 2) post dose (Arms: A, B, C)
Maximum plasma concentration (Cmax).
Time Frame: 24h (Day 2) post dose (Arms: A, B, C)
24h (Day 2) post dose (Arms: A, B, C)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to the maximum plasma concentration (Tmax).
Time Frame: 24h (Day 2) post dose (Arms: A, B, C)
24h (Day 2) post dose (Arms: A, B, C)
Terminal elimination half-life (t½).
Time Frame: 24h (Day 2) post dose (Arms: A, B, C)
24h (Day 2) post dose (Arms: A, B, C)
Apparent total body clearance (CL/F)
Time Frame: 24h (Day 2) post dose (Arms: A, B, C)
24h (Day 2) post dose (Arms: A, B, C)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
Time Frame: 24h (Day 2) post dose (Arms: A, B, C)
24h (Day 2) post dose (Arms: A, B, C)
Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.
Time Frame: 12 to 14 days after the last dose of 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
Area under the curve extrapolated to infinity (AUC0-∞).
Time Frame: 24h (Day 2) post dose (Arms: B, C)
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)
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t).
Time Frame: 24h (Day 2) post dose (Arms: B, C)
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)
Maximum plasma concentration (Cmax).
Time Frame: 24h (Day 2) post dose (Arms: B, C)
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)
Time to the maximum plasma concentration (Tmax).
Time Frame: 24h (Day 2) post dose (Arms: B, C)
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)
Terminal elimination half-life (t½).
Time Frame: 24h (Day 2) post dose (Arms: B, C)
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)
Apparent total body clearance (CL/F)
Time Frame: 24h (Day 2) post dose (Arms: B, C)
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)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F).
Time Frame: 24h (Day 2) post dose (Arms: B, C)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spero Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Melnick, Spero Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPR994-105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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