A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT02770404
- Run by
- Wockhardt
- People needed
- 60
- Starts
- 2016-04-25
- Expected to finish
- 2016-12-25
- Last updated by the study team
- 2018-08-01
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female subject between 18 and 55 years of age, both inclusive,
- creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).
You may not qualify if…
- 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.
- Drug or food allergy.
Where it is running
- Phase 1 unit : Spaulding Clinical Research, LLC — West Bend, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.