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Trial record 65 of 22172 for:    Placebo AND subjects

A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02770404
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Wockhardt

Brief Summary:
This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Nafithromycin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : October 25, 2016
Actual Study Completion Date : December 25, 2016

Arm Intervention/treatment
Experimental: Nafithromycin

Subjects in Cohorts 1 through 5 receive active treatments. Subjects in Cohort 6 will receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period.

Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin on Day 1

Drug: Nafithromycin
100, 200, or 400 mg of nafithromycin

Placebo Comparator: Placebo
Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments.
Drug: Placebo
IV matching placebo
Other Name: Matching IV placebo




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve [ Time Frame: 72 hours from dosing ]
  2. Maximum observed plasma concentration (Cmax) [ Time Frame: 72 hours from dosing ]
  3. Time to Cmax (Tmax) [ Time Frame: 72 hours from dosing ]

Secondary Outcome Measures :
  1. clinical laboratory- Number of subjects with deranged heamatology parameters test results [ Time Frame: 14 days ]
  2. 12-lead safety ECG results [ Time Frame: 14 days ]
  3. Number of subjects reported with any local tolerability at the injection site assessments [ Time Frame: 14 days ]
  4. Number of subjects with any abonormal physical examination findings [ Time Frame: 14 days ]
  5. Total number of reported AEs [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subject between 18 and 55 years of age, both inclusive,
  • creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).

Exclusion Criteria:

  1. Clinically relevant pathology or any other systemic disorder/major surgeries that in the opinion of the investigator would confound the subject's participation and follow-up in the clinical study.
  2. Drug or food allergy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770404


Locations
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United States, Wisconsin
Phase 1 unit : Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Wockhardt

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Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT02770404     History of Changes
Other Study ID Numbers: W-4873-102 SAD study
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Nafithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action