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Safety and Pharmacokinetic Study of PF-06700841 in Japanese Healthy Volunteers

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03236493
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
1.9
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a phase 1 study of PF-06700841. PF-06700841 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-06700841 after multiple oral doses of PF-06700841 in Japanese healthy volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 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-06700841 In Healthy Japanese Subjects
Actual Study Start Date :
Aug 16, 2017
Actual Primary Completion Date :
Sep 17, 2017
Actual Study Completion Date :
Oct 12, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-06700841

Multiple ascending doses of PF-06700841

Drug: PF-06700841
PF-06700841 will be administered as tablet
Placebo Comparator: Placebo

Multiple ascending doses of Placebo

Drug: Placebo
Matching placebo will be administered as tablet

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs [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) [Baseline, 1 hour post-dose on Day 1 and 10]

  3. Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature) [Baseline, Day 1, 10, 13 and 28]

  4. Number of Participants With Change From Baseline in Physical Examinations [Baseline up to Day 28]

  5. Number of Participants With Laboratory Abnormalities [Baseline up to Day 28]

Secondary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) of PF-06700841 at Day 1 [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-06700841 at Day 10 [pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10]

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 at Day 1 [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-06700841 at Day 10 [pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10]

  5. Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 at Day 1 [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-06700841 at Day 1 [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-06700841 at Day 1 [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-06700841 at Day 10 [pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10]

  9. Plasma Decay Half-Life (t1/2) of PF-06700841 at Day 1 [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-06700841 at Day 10 [pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10]

  11. Observed Accumulation Ratio (Rac) on AUCtau for PF-06700841 at Day 10 [pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10]

  12. Observed Accumulation Ratio on Cmax (RacCmax) for PF-06700841 at Day 10 [pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10]

  13. MinimumObserved Plasma Concentration (Cmin) of PF-06700841 at Day 10 [pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Clinical Research Unit Brussels Belgium B-1070

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03236493
Other Study ID Numbers:
  • B7931009
  • 2017-002066-41
First Posted:
Aug 2, 2017
Last Update Posted:
Oct 25, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
PF-06700841

Study Results

No Results Posted as of Oct 25, 2017