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

Sequella

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Drug: Placebo; Drug: PNU-100480

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871949

B1171001

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
• Women of non-childbearing potential only.

Exclusion criteria

• History of hypersensitivity to, or intolerance of, linezolid.
• Antibiotic treatment within 14 days prior to dosing.

Trial design

19 participants in 6 patient groups

Cohort 1, Sequence 1

Experimental group

Description:

Period 1- Placebo Period 2- 100 mg Period 3- 300 mg

Treatment:

Drug: PNU-100480

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Cohort 1, Sequence 2

Experimental group

Description:

Period 1- 35 mg Period 2- Placebo Period 3- 300 mg

Treatment:

Drug: PNU-100480

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Cohort 1, Sequence 3

Experimental group

Description:

Period 1- 35 mg Period 2- 100 mg Period 3- Placebo

Treatment:

Drug: PNU-100480

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Cohort 2, Sequence 1

Experimental group

Description:

Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)

Treatment:

Drug: PNU-100480

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Cohort 2, Sequence 2

Experimental group

Description:

Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)

Treatment:

Drug: PNU-100480

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Cohort 2, Sequence 3

Experimental group

Description:

Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)

Treatment:

Drug: PNU-100480

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo