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

NCT03981887 | Completed Phase 1 FDA Drug

• 1 other identifier: W-4873-105
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• To assess safety

  By measuring treatment emergent AEs

  Day 19

• To assess multiple dose drug tolerability

  By measuring treatment emergent AEs

  Day 19

Secondary Outcomes (4)

• To assess plasma PK parameters profile

  Day 3

• To assess plasma PK parameters profile

  Day 3

• To assess plasma PK parameters profile

  Day 3

• To assess plasma PK parameters profile

  Day 3

Study Arms (2)

Nafithromycin 200 mg as IV infusion

EXPERIMENTAL

Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.

Drug: Nafithromycin

placebo administered as IV infusion

PLACEBO COMPARATOR

Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.

Other: Placebo

Interventions

Nafithromycin DRUG

Nafithromycin 200 mg as IV infusion

Nafithromycin 200 mg as IV infusion

Placebo OTHER

placebo administered as IV infusion

placebo administered as IV infusion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wockhardt: lead
• Clinartis, LLC: collaborator
• Keystone Bioanalytical, Inc.: collaborator

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

nafithromycin

Study Officials

• Carlos Sanabria, MD

  Spaulding Clinical Research LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 11, 2019
• Study Start: June 18, 2019
• Primary Completion: July 2, 2019
• Study Completion: August 7, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

US (1)