Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
This study has been completed.
Sponsor:
Sequella, Inc.
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
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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 (Adult) |
| 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
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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
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:
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 Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016