NCT01225640

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 14, 2016

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

October 19, 2010

Last Update Submit

December 14, 2015

Conditions

Tuberculosis

Keywords

TuberculosisEBAWBA

Outcome Measures

Primary Outcomes (1)

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

    Days 0-2

Secondary Outcomes (10)

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

    Days 2-14

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

    Days 0-14

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

    Days 02-; 2-14; 0-14

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

    Day 1

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

    Day 13-14

  • +5 more secondary outcomes

Study Arms (3)

PNU-100480 600 mg BID

EXPERIMENTAL
Drug: PNU-100480

PNU-100480 1200 mg QD

EXPERIMENTAL
Drug: PNU-100480

RHZE

ACTIVE COMPARATOR

conjugated tablet with 4 drug combination of RHZE, Rifafour® e275 will be used in countries where can be sourced locally

Drug: RHZE

Interventions

PNU-100480DRUG

600 mg twice daily (BID) for 14 days

PNU-100480 600 mg BID
RHZEDRUG

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)

Also known as: Rifafour, Rimstar
RHZE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Bellville, Cape Town, 7530, South Africa

Location

Pfizer Investigational Site

Cape Town, 7700, South Africa

Location

Related Publications (1)

  • Wallis RS, Dawson R, Friedrich SO, Venter A, Paige D, Zhu T, Silvia A, Gobey J, Ellery C, Zhang Y, Eisenach K, Miller P, Diacon AH. Mycobactericidal activity of sutezolid (PNU-100480) in sputum (EBA) and blood (WBA) of patients with pulmonary tuberculosis. PLoS One. 2014 Apr 14;9(4):e94462. doi: 10.1371/journal.pone.0094462. eCollection 2014.

    PMID: 24732289DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

PNU-100480

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Lisa Beth Ferstenberg, M.D.

    Sequella, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 21, 2010

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 14, 2016

Record last verified: 2015-12

Locations

ZA(2)