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CompletedNCT04178577Updated Nov 27, 2020

Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function

A Phase 1 interventional study of Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in Renal Impairment, sponsored by Spero Therapeutics. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-27.

Sponsored by Spero Therapeutics · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Sep 2020, 6 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.

02

Conditions studied

  • Renal Impairment

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Keywords

  • End State Renal Disease (ESRD)
  • Renal Insufficiency
  • Renal Impairment
  • Renal Disease
  • Hemodialysis
03

In context

Renal Insufficiency

1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 39 is close to the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Spero Therapeutics is the lead sponsor of 22 studies on the registry; none are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 3 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • Adult males or females, 18 years of age or older.
  • BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg
  • Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with Renal Disease).
  • Non-smoker for at least 1 month prior to screening for the study.
  • Ability and willingness to abstain from alcohol, caffeine, xanthinecontaining beverages or food.

Key Exclusion Criteria:

  • Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
  • Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec
  • Hemoglobin (HB), hematocrit (HCT), white blood cell count (WBC), or platelet count less than the lower limit of normal range of the reference laboratory (Cohort 1). HB \< 8.5 gm/dL, WBC ≤ 3,000 cells/μL or platelet count ≤ 100,000 cells/μL (Cohorts 2-5).
  • Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 X the upper limit of normal (ULN) for the reference laboratory.
  • Recent history of known or suspected Clostridium difficile infection.
  • History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic academia).
  • History of chronic liver disease, cirrhosis, or biliary disease.
  • History of seizure disorder except childhood history of febrile seizures.
  • Positive urine drug/alcohol testing.
  • Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies.
  • History of substance abuse or alcohol abuse.
  • Use of antacids within 24 hours prior to study drug administration.
  • Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)

    Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.

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

Interventions

  • DrugTebipenem pivoxil hydrobromide (TBPM-PI-HBr)

    Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.

    Also known as: TBPM-PI-HBr, SPR994

06

What researchers measure

Primary outcomes

  1. Apparent total body clearance (CL/F).

    Time frame: 72 hours post dose

  2. Area under the curve from time zero to the last quantifiable sample (AUC0-last).

    Time frame: 72 hours post dose

  3. Area under the curve extrapolated to infinity (AUC0-∞).

    Time frame: 72 hours post dose

  4. Apparent steadystate volume of distribution (Vss/F).

    Time frame: 72 hours post dose

  5. Maximum plasma concentration (Cmax).

    Time frame: 72 hours post dose

  6. Time to the maximum plasma concentration (Tmax).

    Time frame: 72 hours post dose

  7. Terminal elimination half-life (t1/2).

    Time frame: 72 hours post dose

Secondary outcomes

  1. Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.

    AEs will be categorized by system organ class (SOC) and AE preferred term (PT).

    Time frame: 14 days post last dose

  2. Significant changes from baseline in clinical laboratory values.

    All laboratory data will be summarized by cohort, and at each scheduled time-point using descriptive statistics (n, mean, SD, median, minimum, and maximum). E.g. of laboratory values: hematology, biochemistry, coagulation and urinalysis

    Time frame: 14 days post last dose

  3. Significant changes from baseline in physical examination.

    Changes in baseline in physical examination findings (Normal, Abnormal NCS, Abnormal CS) will be summarized using counts and percentages by cohort, and will also be listed individually for each scheduled time-point. Physical examination will include: HEENT; cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance. Additional body systems may be evaluated at the Investigator's discretion.

    Time frame: 14 days post last dose

  4. Significant changes from baseline in vitals signs.

    Vital sign values and changes from baseline at each scheduled time-point will be summarized by cohort for the Safety Analysis Population using descriptive statistics (n, mean, SD, median, minimum, and maximum). Vitals signs will include: systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.

    Time frame: 14 days post last dose

  5. Significant changes from baseline in ECG

    Overall evaluation of safety ECGs will be summarized by cohort, using frequency counts and percentage of subjects as normal or abnormal, and the relevance of the abnormality will be summarized by CS or NCS. ECG parameters will include: heart rate, RR interval, PR interval, QRS, QT and QTcF

    Time frame: 14 days post last dose

  6. Renal clearance (CLR)

    Time frame: 72 hours post dose

  7. Fraction of drug excreted in the urine expressed as a percentage of the TBPM-PI-HBr dose administered (Ae%).

    Time frame: 72 hours post dose

  8. Amount of drug excreted in the urine through 24 hours (Ae0-24), through 48 hours (Ae0-48) and through 72 hours (Ae0-72) for Cohorts 1-4.

    Time frame: 72 hours post dose

  9. For subjects on dialysis, estimated hemodialysis clearance (CLHD) will be assessed.

    Time frame: Up to 1 day post dose - between start and end of hemodialysis.

  10. For subjects on dialysis, the extraction ratio (ER) will be assessed.

    Time frame: Up to 1 day post dose - between start and end of hemodialysis.

  11. For subjects on dialysis, the amount of the dose removed by hemodialysis (XHD) will be assessed.

    Time frame: Up to 1 day post dose - between start and end of hemodialysis.

Other outcomes

  1. For subject in Cohort 1, cumulative amount of TBPM metabolite excreted in urine.

    Time frame: 72 hours post dose

  2. For subjects in Cohort 1, cumulative urinary excretion of TBPM and TBPM metabolite as a % of dose administered.

    Time frame: 72 hours post dose

07

Study locations

2 sites
  • Medical Facility
    Miami, Florida 33136, United States
  • Medical Facility
    Orlando, Florida 32809, United States
08

References and documents

Publications

  • Patel G, Rodvold KA, Gupta VK, Bruss J, Gasink L, Bajraktari F, Lei Y, Jain A, Srivastava P, Talley AK. Pharmacokinetics of Oral Tebipenem Pivoxil Hydrobromide in Subjects with Various Degrees of Renal Impairment. Antimicrob Agents Chemother. 2022 May 17;66(5):e0240721. doi: 10.1128/aac.02407-21. Epub 2022 Apr 14. PubMed 35420493 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04178577
Lead sponsor
Spero Therapeutics
Responsible party
Sponsor
First posted
Nov 26, 2019
Start date
Dec 6, 2019
Primary completion
Sep 6, 2020
Completion
Sep 11, 2020
Last update
Nov 27, 2020

Study contacts

David Melnick, M.D.
study director · Spero Therapeutics Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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