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

NCT04865393 | Completed Phase 1

• 2 other identifiers: SPR206-103CDMRP-JW180095-B
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Time to the maximum plasma concentration (Tmax)

  36 hours after start of study drug IV infusion

• Maximum plasma concentration (Cmax)

  36 hours after start of study drug IV infusion

• Area under the concentration-time curve from time 0 to last measurable timepoint (AUC0-t)

  36 hours after start of study drug IV infusion

• Area under the concentration-time curve from time 0 to infinity (AUC0-∞)

  36 hours after start of study drug IV infusion

Secondary Outcomes (21)

• Area under the concentration-time curve from time 0 to 8 hours (AUC0-8)

  8 hours after start of study drug IV infusion

• Terminal Elimination Rate Constant (kel)

  36 hours after start of study drug IV infusion

• Terminal half-life (t1/2)

  36 hours after start of study drug IV infusion

• Total body clearance (CL)

  36 hours after start of study drug IV infusion

• Renal clearance (CLR)

  36 hours after start of study drug IV infusion

Study Arms (1)

SPR206

EXPERIMENTAL

SPR206 100mg single-dose IV infused over 1 hour

Drug: SPR206

Interventions

SPR206 DRUG

SPR206 100 mg single-dose IV infused over 1 hour

SPR206

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spero Therapeutics: lead
• United States Department of Defense: collaborator

Study Sites (2)

Medical Facility

Auckland, 1010, New Zealand

Location

Medical Facility

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• David Melnick, MD

  Spero Therapeutics Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: June 8, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 6, 2021
• Last Updated: April 15, 2024

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)