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

NCT ID: NCT03981887

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2019-08-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nafithromycin

Intervention Type: DRUG

Nafithromycin 200 mg as IV infusion

placebo administered as IV infusion

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo administered as IV infusion

Interventions

Nafithromycin

Nafithromycin 200 mg as IV infusion

Intervention Type: DRUG

Placebo

placebo administered as IV infusion

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinartis, LLC

UNKNOWN

Sponsor Role: collaborator

Keystone Bioanalytical, Inc.

UNKNOWN

Sponsor Role: collaborator

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Sanabria, MD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Clinical Research LLC

Locations

Spaulding Clinical Research

West Bend, Wisconsin, United States

Countries

United States

Other Identifiers

W-4873-105

Identifier Type: -

Identifier Source: org_study_id