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

Tuberculosis Clinical Trial

Official title:

A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PNU-100480 (PF-02341272) After First Time Administration Of Ascending Oral Doses To Healthy Adult Subjects Under Fed And Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871949
• Other study ID #: B1171001
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2009
• Last updated: August 26, 2013
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2013
• Source: Sequella, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• PNU-100480
100 mg oral suspension given once
• PNU-100480
300 mg oral suspension given once
• Placebo
placebo to match oral suspension given once
• PNU-100480
300 mg oral suspension given once
• PNU-100480
35 mg oral suspension given once
• Placebo
placebo to match oral suspension given once
• PNU-100480
100 mg oral suspension given once
• PNU-100480
35 mg oral suspension given once
• Placebo
placebo to match oral suspension given once
• PNU-100480
1000 mg oral suspension given once
• PNU-100480
1500 mg oral suspension given once
• PNU-100480
Fed conditions, 600 mg oral suspension given once
• Placebo
placebo to match oral suspension given once
• PNU-100480
1500 mg oral suspension given once
• PNU-100480
600 mg oral suspension given once
• PNU-100480
Fed conditions, 600 mg oral suspension given once
• Placebo
placebo to match oral suspension given once
• PNU-100480
1000 mg oral suspension given once
• PNU-100480
600 mg oral suspension given once
• PNU-100480
Fed conditions, 600 mg oral suspension given once
• Placebo
placebo to match oral suspension given once

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Sequella, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Characterize pharmacokinetics of single oral doses PNU-100480.		Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose.	No
Secondary	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.	No
Secondary	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)	No

External Links

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