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

NCT ID: NCT04178577

Last Updated: 2020-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2020-09-11

Brief 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.

Conditions

Renal Impairment

Keywords

End State Renal Disease (ESRD); Renal Insufficiency; Renal Impairment; Renal Disease; Hemodialysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)

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

Group Type: EXPERIMENTAL

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)

Intervention Type: DRUG

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

Interventions

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)

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

Intervention Type: DRUG

Other Intervention Names

TBPM-PI-HBr; SPR994

Eligibility Criteria

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.

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.

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

Sponsors

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Melnick, M.D.

Role: STUDY_DIRECTOR

Spero Therapeutics Inc

Locations

Medical Facility

Miami, Florida, United States

Medical Facility

Orlando, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35420493 (View on PubMed)

Other Identifiers

SPR994-102

Identifier Type: -

Identifier Source: org_study_id