HealthyPhase 1NCT03597217

A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

A Phase 1 study testing PF-05221304 in people with Healthy, run by Pfizer at 1 site in Japan.

Completed

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

Trial summary

The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration. Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-05221304
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteJapan
Study dates: 27 Aug 2018to 15 Nov 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 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lb).

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.

Trial locations and contacts

1 site in 1 country.

Japan1 site

P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071

Other trials in Japan

About this study

Official title: A Phase 1, 2-part Study Of Pf-05221304 In Healthy Japanese Adults: Part 1 - Randomized, Double-blind, Crossover, Single Dose Assessment Of Pharmacokinetics And Safety; Part 2- Randomized, Double-blind, Placebo-controlled, Multiple Dose Assessment Of Safety, Tolerability And Pharmacokinetics Of Pf-05221304

The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.

Conditions: Healthy
Being tested: PF-05221304, Placebo
Keywords: PF-05221304, PK, Japanese, NASH, ACC inhibitor
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

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

PF-05221304Drug
3, 10, 50 mg
PF-05221304Drug
50 mg multiple dose
PlaceboDrug
Placebo

Study groups in NCT03597217
Study group	Role	What they receive
Cohort A_Active	Experimental	3 single doses treatment of PF-05221304 Receives: Drug: PF-05221304
Cohort B_Active	Experimental	Repeated doses of PF-05221304 Receives: Drug: PF-05221304
Cohort B_Placebo	Placebo comparator	Repeated doses of placebo Receives: Drug: Placebo

What is being measured

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

Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Maximum observed plasma concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Time to reach Cmax (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Terminal half life (as data permit) (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Apparent clearance (as data permit) (CL/F)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Apparent volume of distribution (as data permit) (Vz/F)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Number of Subjects experiencing an Adverse Event
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.
Measured: Screening up to 28 days after last dose of study medication

Secondary outcomes (14)

Cohort A: Number of Subjects experiencing an Adverse Event
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.
Measured: Screening up to 28 days after last dose of study medication
Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 1)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Time to reach Cmax (Tmax)(Day 1)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Cohort B: Time to reach Cmax (Tmax)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Minimum plasma concentration during the dosing interval (Cmin)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Peak trough ratio (PTR)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Observed accumulation ratio (Rac)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Observed accumulation ratio for Cmax (Rac,Cmax)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Terminal half life (t1/2)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Apparent volume of distribution (Vz/F)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Apparent clearance (CL/F)(Day 14)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose

Timeline

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

27 Aug 201815 Nov 2018

First posted24 Jul 2018
Study start27 Aug 2018
Primary completion15 Nov 2018
Study completion15 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03597217
Sponsor's protocol ID: C1171013
Status last verified: Nov 2018
First submitted: 12 Jul 2018
Last updated: 27 Nov 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

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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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, 2-part Study Of Pf-05221304 In Healthy Japanese Adults: Part 1 - Randomized, Double-blind, Crossover, Single Dose Assessment Of Pharmacokinetics And Safety; Part 2- Randomized, Double-blind, Placebo-controlled, Multiple Dose Assessment Of Safety, Tolerability And Pharmacokinetics Of Pf-05221304
ClinicalTrials.gov ID: NCT03597217
Acronym / sponsor ID: C1171013
Conditions: Healthy
Keywords: PF-05221304, PK, Japanese, NASH, ACC inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 27 Aug 2018 (actual)
Primary completion: 15 Nov 2018 (actual)
Study completion: 15 Nov 2018 (actual)
First posted: 24 Jul 2018 (actual)
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 current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cohort A_Active	Experimental	Drug: PF-052213043 single doses treatment of PF-05221304
Cohort B_Active	Experimental	Drug: PF-05221304Repeated doses of PF-05221304
Cohort B_Placebo	Placebo comparator	Drug: PlaceboRepeated doses of placebo

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lb).

Key exclusion criteria (1 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.

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
PF-052213043, 10, 50 mg	Drug	Cohort A_Active
PF-0522130450 mg multiple dose	Drug	Cohort B_Active
PlaceboPlacebo	Drug	Cohort B_Placebo

Primary outcome

Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Maximum observed plasma concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Time to reach Cmax (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Terminal half life (as data permit) (t1/2)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Apparent clearance (as data permit) (CL/F)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Apparent volume of distribution (as data permit) (Vz/F)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Number of Subjects experiencing an Adverse Event
Time frame: Screening up to 28 days after last dose of study medication
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.

14 secondary outcomes

Cohort A: Number of Subjects experiencing an Adverse Event
Time frame: Screening up to 28 days after last dose of study medication
Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 1)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Time to reach Cmax (Tmax)(Day 1)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Cohort B: Time to reach Cmax (Tmax)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Minimum plasma concentration during the dosing interval (Cmin)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Peak trough ratio (PTR)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Observed accumulation ratio (Rac)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Observed accumulation ratio for Cmax (Rac,Cmax)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Terminal half life (t1/2)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Apparent volume of distribution (Vz/F)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Apparent clearance (CL/F)(Day 14)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose

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 Nov 2018.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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

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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 PF-05221304 in people with Healthy, run by Pfizer at 1 site in Japan.

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 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 27 Nov 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 Japan. 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. Some participants in this study may receive a placebo. 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?

Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast) (time frame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose). The study lists 8 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 NCT03597217.

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 Nov 2018.