Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nafithromycin; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • West Bend, Wisconsin, United States, 53095
      • Spaulding Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nafithromycin 200 mg as IV infusion; Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.	Drug: Nafithromycin; Nafithromycin 200 mg as IV infusion
PLACEBO_COMPARATOR: placebo administered as IV infusion; Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.	Other: Placebo; placebo administered as IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess safety	By measuring treatment emergent AEs	Day 19
To assess multiple dose drug tolerability	By measuring treatment emergent AEs	Day 19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess plasma PK parameters profile	Area under the plasma concentration-time curve (AUC)	Day 3
To assess plasma PK parameters profile	Maximum observed plasma concentration (Cmax)	Day 3
To assess plasma PK parameters profile	Time to Cmax (Tmax)	Day 3
To assess plasma PK parameters profile	Terminal half-life (t1/2)	Day 3

Collaborators and Investigators

• Sponsor: Wockhardt
• Collaborators: Clinartis, LLC; Keystone Bioanalytical, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2019
• Primary Completion (ACTUAL): July 2, 2019
• Study Completion (ACTUAL): August 7, 2019

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (ACTUAL): June 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Nafithromycin
• Other Study ID Numbers: W-4873-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No