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

July 31, 2018 updated by: Wockhardt

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095
        • Phase 1 unit : Spaulding Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Nafithromycin
100, 200, or 400 mg of nafithromycin
Placebo Comparator: Placebo
Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments.
Drug: Placebo
IV matching placebo
Other Names:
  • Matching IV placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration-time curve
Time Frame: 72 hours from dosing
72 hours from dosing
Maximum observed plasma concentration (Cmax)
Time Frame: 72 hours from dosing
72 hours from dosing
Time to Cmax (Tmax)
Time Frame: 72 hours from dosing
72 hours from dosing

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wockhardt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2016

Primary Completion (Actual)

October 25, 2016

Study Completion (Actual)

December 25, 2016

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W-4873-102 SAD study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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