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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770404
• Other study ID #: W-4873-102 SAD study
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2016
• Est. completion date: December 25, 2016

Study information

• Verified date: July 2018
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 25, 2016
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Nafithromycin
100, 200, or 400 mg of nafithromycin
• Placebo
IV matching placebo

Locations

Country	Name	City	State
United States	Phase 1 unit : Spaulding Clinical Research, LLC	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve		72 hours from dosing
Primary	Maximum observed plasma concentration (Cmax)		72 hours from dosing
Primary	Time to Cmax (Tmax)		72 hours from dosing
Secondary	clinical laboratory- Number of subjects with deranged heamatology parameters test results		14 days
Secondary	12-lead safety ECG results		14 days
Secondary	Number of subjects reported with any local tolerability at the injection site assessments		14 days
Secondary	Number of subjects with any abonormal physical examination findings		14 days
Secondary	Total number of reported AEs		14 days