AzTrials
AzTrials

HealthyPhase 1NCT03232905

Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers

A Phase 1 study testing PF-06651600 in people with Healthy, run by Pfizer at 1 site in Belgium.

Completed

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

Official record
Search all trials

Trial summary

This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-06651600
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteBelgium
Study dates
30 Aug 2017to 22 Nov 2017
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

  • Subject must have four Japanese grandparents who were born in Japan.
  • Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
  • BMI of 17.5 to 27.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of personally signed and dated informed consent document.
  • Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
  • Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
  • Screening blood pressure >140/90 mm Hg.
  • Screening laboratory abnormalities as defined by the protocol.
  • Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit

    Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics After Multiple Oral Doses Of Pf-06651600 In Healthy Japanese Subjects

This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.

Conditions
Healthy
Being tested
PF-06651600, Placebo

What participants receive

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

  • PF-06651600Drug

    PF-06651600 will be administered as tablet

  • PlaceboDrug

    Matching placebo will be administered as tablet

Study groups in NCT03232905
Study groupRoleWhat they receive
PF-06651600ExperimentalMultiple ascending doses of PF-06651600
Receives: Drug: PF-06651600
PlaceboPlacebo comparatorMultiple ascending doses of Placebo
Receives: Drug: Placebo

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs

    Measured: Baseline up to Day 45

  2. Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)

    Measured: Baseline, 1 hour post-dose on Day 1 and 10

  3. Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)

    Measured: Baseline, Day 1, 10, 12 and 28

  4. Number of Participants With Change From Baseline in Physical Examinations

    Measured: Baseline up to Day 28

  5. Number of Participants With Laboratory Abnormalities

    Measured: Baseline up to Day 28

Secondary outcomes (13)

  1. Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

  2. Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

  5. Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

  6. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

  7. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

  8. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

  9. Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

  10. Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

  11. Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

  12. Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

  13. MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10

    Measured: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

Timeline

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

  1. First posted28 Jul 2017
  2. Study start30 Aug 2017
  3. Primary completion27 Oct 2017
  4. Study completion22 Nov 2017

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03232905
Sponsor's protocol ID
B7981008
Other IDs
2017-001298-17, 2017
Status last verified
Dec 2017
First submitted
25 Jul 2017
Last updated
6 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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

Publications

  • Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.

    PubMed 37917289

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06651600 in people with Healthy, run by Pfizer at 1 site in Belgium.

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 6 inclusion and 7 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 6 Dec 2017. 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 Belgium. 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?

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (time frame: Baseline up to Day 45). The study lists 5 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 NCT03232905, 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 6 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in