A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin in Healthy Subjects

Wockhardt1 site in 1 country10 target enrollmentJune 18, 2019

ConditionsHealthy

InterventionsNafithromycin Placebo

DrugsNafithromycin

Overview

Phase: Phase 1
Intervention: Nafithromycin
Conditions: Healthy
Sponsor: Wockhardt
Enrollment: 10
Locations: 1
Primary Endpoint: To assess safety
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:

Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.

Registry

clinicaltrials.gov

Start Date

June 18, 2019

End Date

August 7, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wockhardt

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index (BMI) ≥18 to ≤32 kg/m2, both inclusive.
•Stable health based on a medical history without any major pathology/surgery in the 6 months before Screening and no clinically significant physical examination findings or clinical laboratory test results
•Resting supine blood pressure of 90 to 139 mmHg (systolic) and 60 to 89 mmHg (diastolic) and a resting heart rate of 50 to 100 beats per minute at Screening and Check-in (Day -1).
•Calculated creatinine clearance ≥80 mL/min (Cockroft-Gault method) at Screening.
•Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the investigator

Exclusion Criteria

•Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before study drug administration in this study.
•History/evidence of clinically relevant pathology
•History of clinically significant food or drug allergy
•Positive alcohol or urine drug screen