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
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:
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 September 14, 2014