Status:
COMPLETED
Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function
Lead Sponsor:
Spero Therapeutics
Collaborating Sponsors:
United States Department of Defense
Conditions:
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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) receivi...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04865393
Start Date
June 8 2021
End Date
December 6 2021
Last Update
April 15 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Facility
Auckland, New Zealand, 1010
2
Medical Facility
Christchurch, New Zealand, 8011