Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin
- Registration Number
- NCT03981887
- Lead Sponsor
- Wockhardt
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nafithromycin 200 mg as IV infusion Nafithromycin Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. placebo administered as IV infusion Placebo Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
- Primary Outcome Measures
Name Time Method To assess safety Day 19 By measuring treatment emergent AEs
To assess multiple dose drug tolerability Day 19 By measuring treatment emergent AEs
- Secondary Outcome Measures
Name Time Method To assess plasma PK parameters profile Day 3 Terminal half-life (t1/2)
Trial Locations
- Locations (1)
Spaulding Clinical Research
🇺🇸West Bend, Wisconsin, United States