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A Study Of PNU-100480 In Newly Diagnosed, Treatment Sensitive Patients With Pulmonary Tuberculosis To Assess Early Bactericidal Activity (EBA) And Whole Blood Activity (WBA)

Information source: Sequella, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tuberculosis

Intervention: PNU-100480 (Drug); PNU-100480 (Drug); RHZE (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sequella, Inc.

Official(s) and/or principal investigator(s):
Lisa Beth Ferstenberg, M.D., Study Director, Affiliation: Sequella, Inc.

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.

Clinical Details

Official title: A Phase 2a, Open-Label, Randomized Study In Treatment-Naive, Sputum Smear Positive Subjects With Drug-Sensitive Pulmonary Tuberculosis To Assess Early Bactericidal Activity (EBA) And Whole Blood Activity (WBA) Of PNU-100480 (PF-02341272)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary endpoint is rate of change in sputum log CFU/mL count (EBA) from Days 0-2.

Secondary outcome:

Rate of change in sputum log CFU/mL count (extended EBA).

Rate of change in sputum log CFU/mL count (extended EBA).

Rate of change in culture time to positivity (TTP) measured by MGIT and in log transformed TTP

Cumulative whole blood bactericidal activity (measured as log reduction in CFU) against intracellular M. tuberculosis relative to administered dose and drug PK

Cumulative whole blood bactericidal activity (measured as log reduction in CFU) against intracellular M. tuberculosis relative to administered dose and drug PK

Plasma concentrations of PNU-100480 and PNU-101603 will be used to determine PK parameters (AUCtau, AUC tau,ss, Cmax, Tmax, terminal half-life t1/2, Cavg, Rac) as data permit

Plasma concentrations of PNU-100480 and PNU-101603 will be used to determine PK parameters (AUCtau, AUC tau,ss, Cmax, Tmax, terminal half-life t1/2, Cavg, Rac) as data permit

Safety assessments including physical exams, AEs, laboratory tests, ECGs, and vital signs.

Safety assessments including physical exams, AEs, laboratory tests, ECGs, and vital signs.

Safety assessments including physical exams, AEs, laboratory tests, ECGs, and vital signs.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult males or females between 18 and 65 years; women of childbearing potential must

be willing to adhere to lifestyle requirements regarding contraception/pregnancy prevention.

- Newly diagnosed sputum smear-positive pulmonary TB confirmed with acid-fast bacillus

(AFB) smear and chest x-ray. Patients with TB more than 5 years ago who completed treatment, are healthy, and meet other inclusion criteria may be included.

- Body weight between 40 and 90 kg, inclusive (in light clothing, no shoes).

- Reasonably normal hemoglobin (>=8 gm/dL), renal function (serum creatinine <2 mg/dL),

hepatic function (serum AST <3xULN and total bilirubin <1. 3 mg/dL), and random glucose <150 mg/dL. Exclusion Criteria:

- HIV infection with helper/inducer T-lymphocytes (CD4 cell) count of <=350x10-6/L.

- Presence of significant hemoptysis. Subjects who cough up frank blood (more than

blood streaked sputum) will not be eligible.

- Pregnant or nursing females; females of childbearing potential unwilling or unable to

adhere to contraception guidelines.

- Significant respiratory impairment (respiratory rate >35/minute).

- Clinical suspicion of disseminated TB or tuberculosis meningitis.

- Subjects with diabetes mellitus on insulin and/or who have poorly controlled disease.

- Subjects with confirmed or suspected multi-drug resistant TB.

Locations and Contacts

Pfizer Investigational Site, Cape Town 7700, South Africa

Pfizer Investigational Site, Bellville, Cape Town 7530, South Africa

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2011
Last updated: September 4, 2013

Page last updated: August 23, 2015

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