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

Purpose

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.

Condition	Intervention	Phase
Tuberculosis	Drug: PNU-100480 Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator)
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

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by Sequella, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Characterize pharmacokinetics of single oral doses PNU-100480. [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods) ]


Enrollment:	19
Study Start Date:	April 2009
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1, Sequence 1 Period 1- Placebo Period 2- 100 mg Period 3- 300 mg	Drug: PNU-100480 100 mg oral suspension given once Other Name: Period 2 Drug: PNU-100480 300 mg oral suspension given once Other Name: Period 3 Drug: Placebo placebo to match oral suspension given once Other Name: Period 1
Experimental: Cohort 1, Sequence 2 Period 1- 35 mg Period 2- Placebo Period 3- 300 mg	Drug: PNU-100480 300 mg oral suspension given once Other Name: Period 3 Drug: PNU-100480 35 mg oral suspension given once Other Name: Period 1 Drug: Placebo placebo to match oral suspension given once Other Name: Period 2
Experimental: Cohort 1, Sequence 3 Period 1- 35 mg Period 2- 100 mg Period 3- Placebo	Drug: PNU-100480 100 mg oral suspension given once Other Name: Period 2 Drug: PNU-100480 35 mg oral suspension given once Other Name: Period 1 Drug: Placebo placebo to match oral suspension given once Other Name: Period 3
Experimental: Cohort 2, Sequence 1 Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions)	Drug: PNU-100480 1000 mg oral suspension given once Other Name: Period 2 Drug: PNU-100480 1500 mg oral suspension given once Other Name: Period 3 Drug: PNU-100480 Fed conditions, 600 mg oral suspension given once Other Name: Period 4 (Fed) Drug: Placebo placebo to match oral suspension given once Other Name: Period 1
Experimental: Cohort 2, Sequence 2 Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions)	Drug: PNU-100480 1500 mg oral suspension given once Other Name: Period 3 Drug: PNU-100480 600 mg oral suspension given once Other Name: Period 1 Drug: PNU-100480 Fed conditions, 600 mg oral suspension given once Other Name: Period 4 (Fed) Drug: Placebo placebo to match oral suspension given once Other Name: Period 2
Experimental: Cohort 2, Sequence 3 Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions)	Drug: PNU-100480 1000 mg oral suspension given once Other Name: Period 2 Drug: PNU-100480 600 mg oral suspension given once Other Name: Period 1 Drug: PNU-100480 Fed conditions, 600 mg oral suspension given once Other Name: Period 4 (Fed) Drug: Placebo placebo to match oral suspension given once Other Name: Period 3

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871949

Locations


United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Sequella, Inc.

Investigators


Study Director:	Lisa Beth Ferstenberg, M.D.	Sequella, Inc.

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wallis RS, Jakubiec WM, Kumar V, Silvia AM, Paige D, Dimitrova D, Li X, Ladutko L, Campbell S, Friedland G, Mitton-Fry M, Miller PF. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010 Sep 1;202(5):745-51. doi: 10.1086/655471.


Responsible Party:	Sequella, Inc.
ClinicalTrials.gov Identifier:	NCT00871949 History of Changes
Other Study ID Numbers:	B1171001
Study First Received:	March 27, 2009
Last Updated:	August 26, 2013

Keywords provided by Sequella, Inc.:


Safety tolerability pharmacokinetics PK first in human FIH

Additional relevant MeSH terms:


Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections	Oxazolidinones Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017