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Completed

NCT Number: NCT03232905

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PF-06651600

Drug

PF-06651600 will be administered as tablet

Placebo

Drug

Matching placebo will be administered as tablet

Primary outcomes

  1. 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

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

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

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

    Time frame: Baseline, Day 1, 10, 12 and 28

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

    Time frame: Baseline up to Day 28

  5. Number of Participants With Laboratory Abnormalities

    Time frame: Baseline up to Day 28

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2017
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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