A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2018
Start Date:April 25, 2016
End Date:December 25, 2016

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

This is a Phase 1, randomized, double-blind, single-center, placebo-controlled,
sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in
Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or
placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to
receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover
period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or
400 mg, respectively, of nafithromycin or matching placebo on Day 1.


Inclusion Criteria:

- Male or female subject between 18 and 55 years of age, both inclusive,

- creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).

Exclusion Criteria:

1. Clinically relevant pathology or any other systemic disorder/major surgeries that in
the opinion of the investigator would confound the subject's participation and
follow-up in the clinical study.

2. Drug or food allergy.
We found this trial at
1
site
Phase 1 unit : Spaulding Clinical Research, LLC
West Bend, Wisconsin 53095
Principal Investigator: Carlos Sanabria, MD
Phone: 262-334-6020
?
mi
from
West Bend, WI
Click here to add this to my saved trials