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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05221304; Drug: Placebo

• Registration Number: NCT03597217
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Study Start: 2018-08-27
• Status Verified: 2018-11
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-15
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort A_Active	PF-05221304	3 single doses treatment of PF-05221304
Cohort B_Placebo	Placebo	Repeated doses of placebo
Cohort B_Active	PF-05221304	Repeated doses of PF-05221304

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
Cohort B: Number of Subjects experiencing an Adverse Event	Screening up to 28 days after last dose of study medication	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.

Secondary Outcome Measures

Name	Time	Method
Cohort A: Number of Subjects experiencing an Adverse Event	Screening up to 28 days after last dose of study medication	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.
Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
Cohort B: Area under the plasma concentration time profile from time zero to time τ (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
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
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
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
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

P-one Clinic, Keikokai Medical Corporation; 🇯🇵 Hachioji-shi, Tokyo, Japan