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

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ClinicalTrials.gov Identifier: NCT03232905
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06651600 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 30, 2017
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : November 22, 2017

Arm Intervention/treatment
Experimental: PF-06651600
Multiple ascending doses of PF-06651600
Drug: PF-06651600
PF-06651600 will be administered as tablet

Placebo Comparator: Placebo
Multiple ascending doses of Placebo
Drug: Placebo
Matching placebo will be administered as tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232905


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03232905     History of Changes
Other Study ID Numbers: B7981008
2017-001298-17 ( EudraCT Number )
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No