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

NCT02770404 | Completed Phase 1

• 1 other identifier: W-4873-102 SAD study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve

  72 hours from dosing

• Maximum observed plasma concentration (Cmax)

  72 hours from dosing

• Time to Cmax (Tmax)

  72 hours from dosing

Secondary Outcomes (5)

• clinical laboratory- Number of subjects with deranged heamatology parameters test results

  14 days

• 12-lead safety ECG results

  14 days

• Number of subjects reported with any local tolerability at the injection site assessments

  14 days

• Number of subjects with any abonormal physical examination findings

  14 days

• Total number of reported AEs

  14 days

Study Arms (2)

Nafithromycin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments.

Drug: Placebo

Interventions

Nafithromycin DRUG

100, 200, or 400 mg of nafithromycin

Nafithromycin

Placebo DRUG

IV matching placebo

Also known as: Matching IV placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Phase 1 unit : Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

nafithromycin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: May 12, 2016
• Study Start: April 25, 2016
• Primary Completion: October 25, 2016
• Study Completion: December 25, 2016
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

US (1)