NCT03310463

Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Entasis Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently administered by separate intravenous (IV) infusion in participants with various degrees of renal impairment (RI), in participants with end-stage renal disease (ESRD) who are on hemodialysis (HD), and in healthy matched control participants with normal renal function.

Detailed description

This Phase 1, open-label, non-randomized study evaluates the PK, safety, and tolerability of a single concurrent IV infusion of ETX2514SUL in participants with various degrees of RI, in participants with ESRD who are on HD, and in healthy matched control participants with normal renal function. Participants will be enrolled into five cohorts, according to renal function status, and will receive an IV infusion of ETX2514SUL (single dose of up to 1000 milligrams \[mg\] ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion). Participants in Cohort 5 will receive the ETX2514SUL infusion both post-HD (Period 1) and pre-HD (Period 2).

Conditions

• Acinetobacter Baumannii Infection

Interventions

Type	Name	Description
DRUG	ETX2514SUL	Single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hr IV infusion

Timeline

• Start date: 2017-10-03
• Primary completion: 2018-05-25
• Completion: 2018-05-29
• First posted: 2017-10-16
• Last updated: 2018-06-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study