Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated. Linezolid open label to determine activity in whole blood assay (WBA).

Conditions

• Tuberculosis

Interventions

DRUG

PNU-100480

100 mg BID for 14 days

DRUG

Placebo

to match 100 mg BID for 14 days

DRUG

PNU-100480

300 mg BID for 14 days

DRUG

Placebo

to match 300 mg BID for 14 days

DRUG

PNU-100480

600 mg BID for 14 days

DRUG

Placebo

to match 600 mg BID for 14 days

DRUG

PNU-100480

1200 mg QD for 14 days

DRUG

Placebo

to match 1200 mg QD for 14 days

DRUG

PNU-100480

600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28

DRUG

Placebo

placebo to match 600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28

DRUG

PNU-100480

PNU-100480 dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28

DRUG

Placebo

placebo to match dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28

DRUG

Linezolid

300 mg QD for 4 days (open label)

Sponsors & Collaborators

• Sequella, Inc.

  lead INDUSTRY

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2010-05-31

Completion

2010-05-31

Countries

• United States

Study Locations