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HealthyPhase 1NCT03448172

Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

A Phase 1 study testing [14C]PF-05221304 in people with Healthy, run by Pfizer at 1 site in United States.

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

The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
[14C]PF-05221304
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
18 Apr 2018to 13 Jun 2018
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ages of 18 and 45 years, inclusive.
  • Body mass index (BMI) of >= 17.5 and <= 30.4 kg/m2
  • Total body weight > 50 kg (110 lb).

Who cannot join

  • 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit Inc.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Open Label, Single-period, Non-randomized Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance, And Metabolism Of [14c]Pf-05221304 Administered Orally To Healthy Adult Male Subjects

The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects

Conditions
Healthy
Being tested
[14C]PF-05221304

What participants receive

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

  • [14C]PF-05221304Drug

    a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)

Study groups in NCT03448172
Study groupRoleWhat they receive
Investigational ProductExperimental[14C]PF-05221304
Receives: Drug: [14C]PF-05221304

What is being measured

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

  1. Mass Balance

    Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered

    Measured: 0-96 hr

Secondary outcomes (12)

  1. Metabolic profiling for PF-05221304 in plasma, urine, and feces

    Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces

    Measured: 0-96 hr

  2. Radioactivity AUClast

    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity

    Measured: 0-96 hr

  3. Plasma PF-05221304 AUClast

    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304

    Measured: 0-96 hr

  4. Radioactivity AUCinf

    Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for radioactivity

    Measured: 0-96 hr

  5. Plasma PF-05221304 AUCinf

    Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304

    Measured: 0-96 hr

  6. Radioactivity Cmax

    Maximum Observed Plasma Concentration (Cmax) for radioactivity

    Measured: 0-96 hr

  7. Plasma PF-05221304 Cmax

    Maximum Observed Plasma Concentration (Cmax) for PF-05221304

    Measured: 0-96 hr

  8. Radioactivity Tmax

    Time to Reach Maximum Observed Plasma Concentration for radioactivity

    Measured: 0-96 hr

  9. Plasma PF-05221304 Tmax

    Time to Reach Maximum Observed Plasma Concentration for PF-05221304

    Measured: 0-96 hr

  10. Radioactivity t1/2

    Plasma Decay Half-Life (t1/2) for radioactivity

    Measured: 0-96 hr

  11. Plasma PF-05221304 t1/2

    Plasma Decay Half-Life (t1/2) for PF-05221304

    Measured: 0-96 hr

  12. Number of subjects experiencing an adverse event

    Assessment by physical examinations, adverse event monitoring, clinical laboratory measurements, vital signs and ECG.

    Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity. Treatment-emergent are events between dosing with study drug and up to 28 days after that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

    Measured: Up to 28 days post dosing of IP on Day 1

Timeline

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

  1. First posted27 Feb 2018
  2. Study start18 Apr 2018
  3. Primary completion26 May 2018
  4. Study completion13 Jun 2018

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448172
Sponsor's protocol ID
C1171010
Status last verified
Dec 2018
First submitted
7 Feb 2018
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]PF-05221304 in people with Healthy, run by Pfizer 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 3 inclusion and 1 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 4 Dec 2018. 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?

Mass Balance (time frame: 0-96 hr). 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 NCT03448172.

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 4 Dec 2018.

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