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NCT Number: NCT03597217

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

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.

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Key information

Conditions

Healthy Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, 192-0071, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-05221304

Drug

3, 10, 50 mg

Placebo

Drug

Placebo

Primary outcomes

  1. Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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 outcomes

  1. Cohort A: Number of Subjects experiencing an Adverse Event

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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