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

Phase 1

Completed

• Conditions: Tuberculosis
• Interventions: Drug: PNU-100480; Drug: Placebo

• Registration Number: NCT00871949
• Lead Sponsor: Sequella, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Start: 2009-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1, Sequence 1	PNU-100480	Period 1- Placebo Period 2- 100 mg Period 3- 300 mg
Cohort 1, Sequence 1	Placebo	Period 1- Placebo Period 2- 100 mg Period 3- 300 mg
Cohort 1, Sequence 2	PNU-100480	Period 1- 35 mg Period 2- Placebo Period 3- 300 mg
Cohort 1, Sequence 2	Placebo	Period 1- 35 mg Period 2- Placebo Period 3- 300 mg
Cohort 2, Sequence 3	Placebo	Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)
Cohort 1, Sequence 3	PNU-100480	Period 1- 35 mg Period 2- 100 mg Period 3- Placebo
Cohort 1, Sequence 3	Placebo	Period 1- 35 mg Period 2- 100 mg Period 3- Placebo
Cohort 2, Sequence 1	PNU-100480	Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
Cohort 2, Sequence 1	Placebo	Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
Cohort 2, Sequence 2	PNU-100480	Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)
Cohort 2, Sequence 3	PNU-100480	Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)
Cohort 2, Sequence 2	Placebo	Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)

Primary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability of escalating single oral doses of PNU-100480.	Daily, Days 1-3 or 4, and 7-14 days after dosing.

Secondary Outcome Measures

Name	Time	Method
Characterize pharmacokinetics of single oral doses PNU-100480.	Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.
Characterize the effect of food on the pharmacokinetics of a single oral dose of PNU-100480.	Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.
Characterize the bactericidal activity in blood of orally administered PNU-100480 against intracellular Mycobacterium tuberculosis in relation to blood concentrations of PNU-100480 (and its metabolites) (some periods only)	Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States