NCT01218217

Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB

A Phase 2A Trial to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of SQ109 in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Michael Hoelscher · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

SQ109 was developed with the aim of shortening TB treatment and providing new drugs for resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable safety profile in first-in-man studies. The objective of this study is to evaluate the extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB.

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	SQ109	SQ109 150 mg tablet
DRUG	Rifampicin	Rifampicin 150 mg capsules

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-09-01
• Completion: 2012-05-01
• First posted: 2010-10-11
• Last updated: 2013-01-14

Locations

2 sites across 1 country: South Africa