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

NCT ID: NCT04865393

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2021-12-06

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) receiving hemodialysis (HD) therapy.

Conditions

Renal Impairment

Study Design

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

Study Groups

SPR206

SPR206 100mg single-dose IV infused over 1 hour

Group Type: EXPERIMENTAL

SPR206

Intervention Type: DRUG

SPR206 100 mg single-dose IV infused over 1 hour

Interventions

SPR206

SPR206 100 mg single-dose IV infused over 1 hour

Intervention Type: DRUG

Eligibility Criteria

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

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

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

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Melnick, MD

Role: STUDY_DIRECTOR

Spero Therapeutics Inc

Locations

Medical Facility

Auckland, , New Zealand

Medical Facility

Christchurch, , New Zealand

Countries

New Zealand

Other Identifiers

CDMRP-JW180095-B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPR206-103

Identifier Type: -

Identifier Source: org_study_id