Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
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ClinicalTrials.gov Identifier: NCT00871949 |
Recruitment Status
:
Completed
First Posted
: March 30, 2009
Last Update Posted
: August 27, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis | Drug: PNU-100480 Drug: Placebo | Phase 1 |
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 |

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
|
- 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. ]
- 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) ]

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

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
United States, Connecticut | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06511 |
Study Director: | Lisa Beth Ferstenberg, M.D. | Sequella, Inc. |
Additional Information:
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 |