Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

Spero Therapeutics

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Treatments

Drug: SPR206

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT04865393

SPR206-103

CDMRP-JW180095-B (Other Grant/Funding Number)

Details and patient eligibility

About

Evaluation of the pharmacokinetics (PK) of SPR206 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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive)
Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees of Renal Disease)
Normal renal function with eGFR ≥90 mL/min/1.73m2 (Cohort 1), or renal insufficiency with eGFR 60 to <90 mL/min/1.73m2 (Cohort 2), 30 to <60 mL/min/1.73m2 (Cohort 3), or <30 mL/min/1.73m2 (Cohort 4), calculated using Modification of Diet in Renal Disease (MDRD). Subjects with ESRD must be receiving hemodialysis at least 3 times per week for at least 3 months at Screening (Cohort 5 only)
Non-smoker for at least 1 month prior to screening for the study
Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food
Other inclusion criteria per protocol

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 (within 6 months) of known or suspected Clostridium difficile infection
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 virus1/2 (HIV 1/2), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies
History of substance abuse or alcohol abuse
Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
Other exclusion criteria per protocol