A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

Healthy Clinical Trial

Official title:

A Phase 1, 2-part Study Of Pf-05221304 In Healthy Japanese Adults: Part 1 - Randomized, Double-blind, Crossover, Single Dose Assessment Of Pharmacokinetics And Safety; Part 2- Randomized, Double-blind, Placebo-controlled, Multiple Dose Assessment Of Safety, Tolerability And Pharmacokinetics Of Pf-05221304

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597217
• Other study ID #: C1171013
• Status: Completed
• Phase: Phase 1
• Start date: August 27, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.

• Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-05221304
3, 10, 50 mg
• PF-05221304
50 mg multiple dose
• Placebo
Placebo

Locations

Country	Name	City	State
Japan	P-one Clinic, Keikokai Medical Corporation	Hachioji-shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)		0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Primary	Cohort A: Maximum observed plasma concentration (Cmax)		0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Primary	Cohort A: Time to reach Cmax (Tmax)		0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Primary	Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf)		0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Primary	Cohort A: Terminal half life (as data permit) (t1/2)		0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Primary	Cohort A: Apparent clearance (as data permit) (CL/F)		0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Primary	Cohort A: Apparent volume of distribution (as data permit) (Vz/F)		0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Primary	Cohort B: Number of Subjects experiencing an Adverse Event	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.	Screening up to 28 days after last dose of study medication
Secondary	Cohort A: Number of Subjects experiencing an Adverse Event	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.	Screening up to 28 days after last dose of study medication
Secondary	Cohort B: Area under the plasma concentration time profile from time zero to time t (tau), the dosing interval (ACUtau)(Day 1)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Secondary	Cohort B: Area under the plasma concentration time profile from time zero to time t (tau), the dosing interval (ACUtau)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 1)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Secondary	Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Time to reach Cmax (Tmax)(Day 1)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Secondary	Cohort B: Time to reach Cmax (Tmax)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Minimum plasma concentration during the dosing interval (Cmin)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Peak trough ratio (PTR)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Observed accumulation ratio (Rac)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Observed accumulation ratio for Cmax (Rac,Cmax)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Terminal half life (t1/2)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Apparent volume of distribution (Vz/F)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Secondary	Cohort B: Apparent clearance (CL/F)(Day 14)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose

External Links

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