Healthy Clinical Trial
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
Verified date | December 2017 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | November 22, 2017 |
Est. primary completion date | October 27, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Pfizer Clinical Research Unit | Brussels |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Baseline up to Day 45 | ||
Primary | 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 | ||
Primary | Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature) | Baseline, Day 1, 10, 12 and 28 | ||
Primary | Number of Participants With Change From Baseline in Physical Examinations | Baseline up to Day 28 | ||
Primary | Number of Participants With Laboratory Abnormalities | Baseline up to Day 28 | ||
Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | ||
Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | ||
Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | ||
Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | ||
Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | ||
Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | ||
Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | ||
Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | ||
Secondary | Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | ||
Secondary | Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | ||
Secondary | Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | ||
Secondary | Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | ||
Secondary | MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |
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