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

Sequella

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Drug: Linezolid; Drug: Placebo; Drug: PNU-100480

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990990

B1171002

Details and patient eligibility

About

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).

Full description

Evaluate safety, tolerability, pharmacokinetics and whole blood activity (WBA) of PNU-100480 given for 14 or 28 days; evaluate WBA of PNU with pyrazinamide; evaluate WBA of linezolid

Enrollment: 59 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, or any previous antibiotic use at the discretion of the investigator.
• Previous history of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).

Trial design

59 participants in 7 patient groups

Cohort 1

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Cohort 2

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Cohort 3

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Cohort 4

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Cohort 5

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Cohort 6 (optional)

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: Placebo

Drug: PNU-100480

Drug: Placebo

Drug: PNU-100480

Drug: PNU-100480

Linezolid Cohort

Experimental group

Treatment:

Drug: Linezolid