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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sequella, Inc.
ClinicalTrials.gov Identifier:
NCT00871949
First received: March 27, 2009
Last updated: August 26, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:


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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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:
No publications provided by Sequella, Inc.

Additional 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
Study First Received: March 27, 2009
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014