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

S

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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