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
| Registry | NCT03236493 |
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| Status | Completed |
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| Phase | Phase 1 |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 8 (Actual) |
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| Sponsor | Pfizer (Industry) |
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| Conditions | Healthy |
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| Interventions | PF-06700841, Placebo (Drug) |
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| Dates | start 2017-08-16, primary completion 2017-09-17, completion 2017-10-12, first posted 2017-08-02, last updated 2017-10-25 |
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| Locations | 1 site in Belgium |
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Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of PF-06700841 All trials of Placebo
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| PF-06700841 | Experimental | Drug: PF-06700841 | Multiple ascending doses of PF-06700841 |
| Placebo | Placebo comparator | Drug: Placebo | Multiple ascending doses of Placebo |
- PF-06700841 (Drug): PF-06700841 will be administered as tablet
- Placebo (Drug): Matching placebo will be administered as tablet
+Outcome measures
Primary outcomes
- Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs [Baseline up to Day 45]
- 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]
- Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature) [Baseline, Day 1, 10, 13 and 28]
- Number of Participants With Change From Baseline in Physical Examinations [Baseline up to Day 28]
- Number of Participants With Laboratory Abnormalities [Baseline up to Day 28]
Secondary outcomes
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
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.
+Locations (1)
| Facility | City | Country | Status |
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| Pfizer Clinical Research Unit | Brussels | Belgium | |
+Publications
- Results publication: Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31. PMID 36045513
+Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
+Funding