Clinical trial NCT03232905: Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
timeFrame: Baseline up to Day 45
measure: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)
timeFrame: Baseline, 1 hour post-dose on Day 1 and 10
measure: Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)
timeFrame: Baseline, Day 1, 10, 12 and 28
measure: Number of Participants With Change From Baseline in Physical Examinations
timeFrame: Baseline up to Day 28
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Day 28
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10
timeFrame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: