Clinical Trial: Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 1 Open Label Trial of the Safety, Tolerability, and Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin
Brief Summary: This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.
Detailed Summary: This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. A total of 28 subjects (14 male, 14 female) will be enrolled and will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally. The study duration is approximately 18 months. Study Objectives: The primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose. The secondary objective is to determine the safety and tolerability of a single 1000 mg oral dose of solithromycin in healthy adult subjects.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: The pharmacokinetics of solithromycin will be assessed by measurement of solithromycin levels in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples at multiple time points after drug administration. [ Time Frame: Day 1 to Day 3 ]
Original Primary Outcome:
- The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by solicited and unsolicited adverse effects, laboratory tests, ECGs, physical exams, and vital signs. [ Time Frame: Day 1 to Day 7 ]
- The pharmacokinetics of solithromycin will be assessed by measurement of solithromycin levels in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples at multiple time points after drug administration. [ Time Frame: Day 1 to Day 3 ]
Current Secondary Outcome:
- The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by comparing ECGs to baseline ECGs [ Time Frame: Day 1 to Day 7 ]
- The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by laboratory analysis. [ Time Frame: Day 1 to Day 7 ]
- The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by reported adverse effects [ Time Frame: Day 1 to Day 7 ]
- The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by rotine vital signs [ Time Frame: Day 1 to Day 7 ]
- The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by routine physical exams [ Time Frame: Day 1 to Day 7 ]
Original Secondary Outcome:
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: January 22, 2015
Date Started: May 5, 2015
Date Completion:
Last Updated: April 6, 2017
Last Verified: April 5, 2017