Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.

Conditions

• Tuberculosis

Interventions

DRUG

PNU-100480

100 mg oral suspension given once

DRUG

PNU-100480

300 mg oral suspension given once

DRUG

Placebo

placebo to match oral suspension given once

DRUG

PNU-100480

300 mg oral suspension given once

DRUG

PNU-100480

35 mg oral suspension given once

DRUG

Placebo

placebo to match oral suspension given once

DRUG

PNU-100480

100 mg oral suspension given once

DRUG

PNU-100480

35 mg oral suspension given once

DRUG

Placebo

placebo to match oral suspension given once

DRUG

PNU-100480

1000 mg oral suspension given once

DRUG

PNU-100480

1500 mg oral suspension given once

DRUG

PNU-100480

Fed conditions, 600 mg oral suspension given once

DRUG

Placebo

placebo to match oral suspension given once

DRUG

PNU-100480

1500 mg oral suspension given once

DRUG

PNU-100480

600 mg oral suspension given once

DRUG

PNU-100480

Fed conditions, 600 mg oral suspension given once

DRUG

Placebo

placebo to match oral suspension given once

DRUG

PNU-100480

1000 mg oral suspension given once

DRUG

PNU-100480

600 mg oral suspension given once

DRUG

PNU-100480

Fed conditions, 600 mg oral suspension given once

DRUG

Placebo

placebo to match oral suspension given once

Sponsors & Collaborators

• Sequella, Inc.

  lead INDUSTRY

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2009-08-31

Completion

2009-08-31

Countries

• United States

Study Locations