ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00871949
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
Sequella, Inc.

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: PNU-100480 Drug: Placebo Phase 1

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Characterize pharmacokinetics of single oral doses PNU-100480. [ Time Frame: Predose; multiple timepoints postdose on Day 1, and up to 72 hours postdose. ]
  2. 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. ]
  3. 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) ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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):

Responsible Party: Sequella, Inc.
ClinicalTrials.gov Identifier: NCT00871949     History of Changes
Other Study ID Numbers: B1171001
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 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