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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03597217
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-05221304; Drug: PF-05221304; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Aug 27, 2018
• Actual Primary Completion Date: Nov 15, 2018
• Actual Study Completion Date: Nov 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A_Active 3 single doses treatment of PF-05221304	Drug: PF-05221304; 3, 10, 50 mg
Experimental: Cohort B_Active Repeated doses of PF-05221304	Drug: PF-05221304; 50 mg multiple dose
Placebo Comparator: Cohort B_Placebo Repeated doses of placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

8. 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

1. 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.

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

8. 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]

9. 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]

10. 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]

11. 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]

12. 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]

13. 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]

14. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	P-one Clinic, Keikokai Medical Corporation	Hachioji-shi	Tokyo	Japan	192-0071

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03597217
• Other Study ID Numbers: C1171013
• First Posted: Jul 24, 2018
• Last Update Posted: Nov 27, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Pfizer: PF-05221304, PK, Japanese, NASH, ACC inhibitor

Study Results

No Results Posted as of Nov 27, 2018