Biological AvailabilityPhase 1NCT01267201

A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form

A Phase 1 study testing methylprednisolone in people with Biological Availability, run by Pfizer at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers. Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Biological Availability
What is being tested?: methylprednisolone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteSingapore
Study dates: Nov 2010to Dec 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;
a total body weight >45 kg (99 lbs).

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
Any condition possibly affecting drug absorption (eg, gastrectomy).

Trial locations and contacts

1 site in 1 country.

Singapore1 site

Pfizer Investigational Site
Singapore, 188770

Other trials in Singapore

About this study

Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions

Conditions: Biological Availability
Being tested: methylprednisolone
Keywords: Single dose bioavailability study of methylprednisolone powder for oral suspension (4mg/mL) versus methylprednisolone tablet (32 mg)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

methylprednisoloneDrug
powder for oral suspension 4 mg/mL single dose (8 mL)
methylprednisoloneDrug
powder for oral suspension 4 mg/mL singe dose (8 ml)
methylprednisoloneDrug
tablet 32 mg single dose

Study groups in NCT01267201
Study group	Role	What they receive
POS formulation #1	Experimental	Not described Receives: Drug: methylprednisolone
POS formulation #2	Experimental	Not described Receives: Drug: methylprednisolone
commercial tablet	Active comparator	Not described Receives: Drug: methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Secondary outcomes (2)

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
Plasma Decay Half-life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Dec 2010

First posted28 Dec 2010 (estimated)
Study startNov 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Biological AvailabilityStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01267201
Sponsor's protocol ID: B0121005
Status last verified: May 2012
First submitted: 13 Dec 2010
Last updated: 28 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Biological Availability trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions
ClinicalTrials.gov ID: NCT01267201
Acronym / sponsor ID: B0121005
Conditions: Biological Availability
Keywords: Single dose bioavailability study of methylprednisolone powder for oral suspension (4mg/mL) versus methylprednisolone tablet (32 mg)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 28 Dec 2010 (estimated)
Results: Posted 28 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
POS formulation #1	Experimental	Drug: methylprednisolone
POS formulation #2	Experimental	Drug: methylprednisolone
commercial tablet	Active comparator	Drug: methylprednisolone

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;
a total body weight >45 kg (99 lbs).

Key exclusion criteria (2 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
Any condition possibly affecting drug absorption (eg, gastrectomy).

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
methylprednisolonepowder for oral suspension 4 mg/mL single dose (8 mL)	Drug	POS formulation #1
methylprednisolonepowder for oral suspension 4 mg/mL singe dose (8 ml)	Drug	POS formulation #2
methylprednisolonetablet 32 mg single dose	Drug	commercial tablet

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

2 secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
Plasma Decay Half-life (t1/2)
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Results and safety

Results posted to the registry on 28 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methylprednisolone 32 mg Tablet, Formulation 1, Formulation 2	4	3
Methylprednisolone 32 mg Tablet, Formulation 2, Formulation 1	4	4
Methylprednisolone Formulation 1, 32 mg Tablet, Formulation 2	4	4
Methylprednisolone Formulation 1, Formulation 2, 32 mg Tablet	4	4
Methylprednisolone Formulation 2, 32 mg Tablet, Formulation 1	4	4
Methylprednisolone Formulation 2, Formulation 1, 32 mg Tablet	4	4

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose. Geometric mean (Standard Deviation). Unit: ng*hr/mL

Measure	Methylprednisolone 32 mg Tablet n = 24	Methylprednisolone 32 mg Micronized API n = 22	Methylprednisolone 32 mg Sieve Cut API n = 23
Value	1286.00 (385.27)	1204.00 (394.65)	1180.00 (355.26)

Methylprednisolone 32 mg Tablet vs Methylprednisolone 32 mg Micronized API: Ratio of adjusted geometric means: 92.11 (90% CI 88.23 to 96.15)
Methylprednisolone 32 mg Tablet vs Methylprednisolone 32 mg Sieve Cut API: Ratio of adjusted geometric means: 90.22 (90% CI 86.49 to 94.11)

Population analysed: Pharmacokinetic (PK) parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose. Geometric mean (Standard Deviation). Unit: ng/mL

Measure	Methylprednisolone 32 mg Tablet n = 24	Methylprednisolone 32 mg Micronized API n = 22	Methylprednisolone 32 mg Sieve Cut API n = 23
Value	289.00 (60.42)	279.10 (82.91)	246.20 (66.05)

Methylprednisolone 32 mg Tablet vs Methylprednisolone 32 mg Micronized API: Ratio of adjusted geometric means: 94.76 (90% CI 88.06 to 101.98)
Methylprednisolone 32 mg Tablet vs Methylprednisolone 32 mg Sieve Cut API: Ratio of adjusted geometric means: 83.89 (90% CI 78.06 to 90.17)

Population analysed: PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methylprednisolone 32 mg Tablet	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Methylprednisolone 32 mg Micronized API	0 of 22 (0%)	0 of 22 (0%)	Not reported
Methylprednisolone 32 mg Sieve Cut API	0 of 23 (0%)	1 of 23 (4.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Pfizer CT.gov Call Center study director

Pfizer

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 methylprednisolone in people with Biological Availability, run by Pfizer at 1 site in Singapore.

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 28 Jun 2012. 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 Singapore. 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?

Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose). The study lists 2 primary outcomes in all. 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 NCT01267201.

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 28 Jun 2012.