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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: Nafithromycin

• Registration Number: NCT02770404
• Lead Sponsor: Wockhardt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-09
• Study Start: 2016-04-25
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2016-10-25
• Study Completion: 2016-12-25
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments.
Nafithromycin	Nafithromycin	Subjects in Cohorts 1 through 5 receive active treatments. Subjects in Cohort 6 will 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 on Day 1

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	72 hours from dosing
Time to Cmax (Tmax)	72 hours from dosing
Area under the plasma concentration-time curve	72 hours from dosing

Secondary Outcome Measures

Name	Time	Method
clinical laboratory- Number of subjects with deranged heamatology parameters test results	14 days
Number of subjects with any abonormal physical examination findings	14 days
12-lead safety ECG results	14 days
Number of subjects reported with any local tolerability at the injection site assessments	14 days
Total number of reported AEs	14 days

Trial Locations

Locations (1)

Phase 1 unit : Spaulding Clinical Research, LLC; 🇺🇸 West Bend, Wisconsin, United States