NCT02348424

Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

Phase 1 Open Label Trial of the Safety, Tolerability, and Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Gonorrhoea

Interventions

Type	Name	Description
DRUG	Solithromycin	Cohorts 1 and 2 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.

Timeline

• Start date: 2015-05-05
• Primary completion: 2017-01-13
• Completion: 2017-01-13
• First posted: 2015-01-28
• Last updated: 2019-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study