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PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay

NCT01225640 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-01-14

No results posted yet for this study

Summary

PNU-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480 when given for 14 days to treatment-naive patients with drug-sensitive pulmonary tuberculosis.

Conditions

Interventions

DRUG

PNU-100480

600 mg twice daily (BID) for 14 days

DRUG

PNU-100480

1200 mg once daily (QD) for 14 days

DRUG

RHZE

Combination tablet (RHZE) dosed by weight. Dosage strength per tablet is 150 mg Rifampicin (R)/75 mg Isoniazid (H)/400 mg Pyrazinamide (Z)/275 mg Ethambutol (E)

Sponsors & Collaborators

  • Sequella, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Beth Ferstenberg, M.D. · Sequella, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225640 on ClinicalTrials.gov