TuberculosisPhase 1NCT00871949
Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults
A Phase 1 study testing PNU-100480 in people with Tuberculosis, run by Sequella, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- PNU-100480
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of hypersensitivity to, or intolerance of, linezolid.
- Antibiotic treatment within 14 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
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
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.
- Conditions
- Tuberculosis
- Being tested
- PNU-100480, Placebo
- Keywords
- Safety tolerability pharmacokinetics PK first in human FIH
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNU-100480Drug
Also called Period 2
100 mg oral suspension given once
PNU-100480Drug
Also called Period 3
300 mg oral suspension given once
PlaceboDrug
Also called Period 1
placebo to match oral suspension given once
PNU-100480Drug
Also called Period 3
300 mg oral suspension given once
PNU-100480Drug
Also called Period 1
35 mg oral suspension given once
PlaceboDrug
Also called Period 2
placebo to match oral suspension given once
PNU-100480Drug
Also called Period 2
100 mg oral suspension given once
PNU-100480Drug
Also called Period 1
35 mg oral suspension given once
PlaceboDrug
Also called Period 3
placebo to match oral suspension given once
PNU-100480Drug
Also called Period 2
1000 mg oral suspension given once
PNU-100480Drug
Also called Period 3
1500 mg oral suspension given once
PNU-100480Drug
Also called Period 4 (Fed)
Fed conditions, 600 mg oral suspension given once
PlaceboDrug
Also called Period 1
placebo to match oral suspension given once
PNU-100480Drug
Also called Period 3
1500 mg oral suspension given once
PNU-100480Drug
Also called Period 1
600 mg oral suspension given once
PNU-100480Drug
Also called Period 4 (Fed)
Fed conditions, 600 mg oral suspension given once
PlaceboDrug
Also called Period 2
placebo to match oral suspension given once
PNU-100480Drug
Also called Period 2
1000 mg oral suspension given once
PNU-100480Drug
Also called Period 1
600 mg oral suspension given once
PNU-100480Drug
Also called Period 4 (Fed)
Fed conditions, 600 mg oral suspension given once
PlaceboDrug
Also called Period 3
placebo to match oral suspension given once
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Sequence 1 | Experimental | Period 1- Placebo Period 2- 100 mg Period 3- 300 mg Receives: Drug: PNU-100480; Drug: Placebo |
| Cohort 1, Sequence 2 | Experimental | Period 1- 35 mg Period 2- Placebo Period 3- 300 mg Receives: Drug: PNU-100480; Drug: Placebo |
| Cohort 1, Sequence 3 | Experimental | Period 1- 35 mg Period 2- 100 mg Period 3- Placebo Receives: Drug: PNU-100480; Drug: Placebo |
| Cohort 2, Sequence 1 | Experimental | Period 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions) Receives: Drug: PNU-100480; Drug: Placebo |
| Cohort 2, Sequence 2 | Experimental | Period 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions) Receives: Drug: PNU-100480; Drug: Placebo |
| Cohort 2, Sequence 3 | Experimental | Period 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions) Receives: Drug: PNU-100480; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and tolerability of escalating single oral doses of PNU-100480.
Measured: Daily, Days 1-3 or 4, and 7-14 days after dosing.
Secondary outcomes (3)
Characterize pharmacokinetics of single oral doses PNU-100480.
Measured: 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.
Measured: 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)
Measured: Predose and timpoints up to 24 hours post dose on Day 1 (only in some periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequella, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Beth Ferstenberg, M.D., Study director, Sequella, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871949
- Sponsor's protocol ID
- B1171001
- Status last verified
- Aug 2013
- First submitted
- 27 Mar 2009
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wallis RS, Jakubiec WM, Kumar V, Silvia AM, Paige D, Dimitrova D, Li X, Ladutko L, Campbell S, Friedland G, Mitton-Fry M, Miller PF. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010 Sep 1;202(5):745-51. doi: 10.1086/655471.
PubMed 20629533
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00871949
- Acronym / sponsor ID
- B1171001
- Conditions
- Tuberculosis
- Keywords
- Safety tolerability pharmacokinetics PK first in human FIH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sequella, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Sequence 1 | Experimental | Drug: PNU-100480, Drug: PlaceboPeriod 1- Placebo Period 2- 100 mg Period 3- 300 mg |
| Cohort 1, Sequence 2 | Experimental | Drug: PNU-100480, Drug: PlaceboPeriod 1- 35 mg Period 2- Placebo Period 3- 300 mg |
| Cohort 1, Sequence 3 | Experimental | Drug: PNU-100480, Drug: PlaceboPeriod 1- 35 mg Period 2- 100 mg Period 3- Placebo |
| Cohort 2, Sequence 1 | Experimental | Drug: PNU-100480, Drug: PlaceboPeriod 1- Placebo Period 2- 1000 mg Period 3- 1500 mg Period 4- 600 mg (Fed conditions) |
| Cohort 2, Sequence 2 | Experimental | Drug: PNU-100480, Drug: PlaceboPeriod 1- 600 mg Period 2- Placebo Period 3- 1500 mg Period 4- 600 mg (Fed conditions) |
| Cohort 2, Sequence 3 | Experimental | Drug: PNU-100480, Drug: PlaceboPeriod 1- 600 mg Period 2- 1000 mg Period 3- Placebo Period 4- 600 mg (Fed conditions) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- History of hypersensitivity to, or intolerance of, linezolid.
- Antibiotic treatment within 14 days prior to dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNU-100480Also: Period 2100 mg oral suspension given once | Drug | Cohort 1, Sequence 1 |
| PNU-100480Also: Period 3300 mg oral suspension given once | Drug | Cohort 1, Sequence 1 |
| PlaceboAlso: Period 1placebo to match oral suspension given once | Drug | Cohort 1, Sequence 1 |
| PNU-100480Also: Period 3300 mg oral suspension given once | Drug | Cohort 1, Sequence 2 |
| PNU-100480Also: Period 135 mg oral suspension given once | Drug | Cohort 1, Sequence 2 |
| PlaceboAlso: Period 2placebo to match oral suspension given once | Drug | Cohort 1, Sequence 2 |
| PNU-100480Also: Period 2100 mg oral suspension given once | Drug | Cohort 1, Sequence 3 |
| PNU-100480Also: Period 135 mg oral suspension given once | Drug | Cohort 1, Sequence 3 |
| PlaceboAlso: Period 3placebo to match oral suspension given once | Drug | Cohort 1, Sequence 3 |
| PNU-100480Also: Period 21000 mg oral suspension given once | Drug | Cohort 2, Sequence 1 |
| PNU-100480Also: Period 31500 mg oral suspension given once | Drug | Cohort 2, Sequence 1 |
| PNU-100480Also: Period 4 (Fed)Fed conditions, 600 mg oral suspension given once | Drug | Cohort 2, Sequence 1 |
| PlaceboAlso: Period 1placebo to match oral suspension given once | Drug | Cohort 2, Sequence 1 |
| PNU-100480Also: Period 31500 mg oral suspension given once | Drug | Cohort 2, Sequence 2 |
| PNU-100480Also: Period 1600 mg oral suspension given once | Drug | Cohort 2, Sequence 2 |
| PNU-100480Also: Period 4 (Fed)Fed conditions, 600 mg oral suspension given once | Drug | Cohort 2, Sequence 2 |
| PlaceboAlso: Period 2placebo to match oral suspension given once | Drug | Cohort 2, Sequence 2 |
| PNU-100480Also: Period 21000 mg oral suspension given once | Drug | Cohort 2, Sequence 3 |
| PNU-100480Also: Period 1600 mg oral suspension given once | Drug | Cohort 2, Sequence 3 |
| PNU-100480Also: Period 4 (Fed)Fed conditions, 600 mg oral suspension given once | Drug | Cohort 2, Sequence 3 |
| PlaceboAlso: Period 3placebo to match oral suspension given once | Drug | Cohort 2, Sequence 3 |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
- Derived from this study: PubMed 20629533Wallis RS, Jakubiec WM, Kumar V, Silvia AM, Paige D, Dimitrova D, Li X, Ladutko L, Campbell S, Friedland G, Mitton-Fry M, Miller PF. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis. 2010 Sep 1;202(5):745-51. doi: 10.1086/655471.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Beth Ferstenberg, M.D. study director
Sequella, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PNU-100480 in people with Tuberculosis, run by Sequella, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.