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Completed

NCT Number: NCT04388878

Study Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants

The purpose of the study is to evaluate the safety, tolerability, and PK of single escalating doses and multiple escalating doses of PF-07054894.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female (of non-child bearing potential) participants must be 18 to 55 years of age, inclusive, and with BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Male and female of non-child bearing potential participants who are overtly healthy as determined by medical evaluation.
  • Participants must be willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure, from admission to FU1 and to apply sun screen/lotion with a high sun protection factor, as appropriate.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological, or allergic diseases.
  • Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB), history of HIV infection, hepatitis B, or hepatitis C.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Have a history of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
  • History of phototoxicity and photosensitivity.

Treatment and study plan

PF-07054894

Drug

Participants will receive oral ascending doses

Placebo

Drug

Participants will receive matching placebo

Primary outcomes

  1. AEs following Single ascending dose (SAD)

    Time frame: Day 1 up to Day 28 (SAD)

    Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs

  2. AEs following multiple ascending dose (MAD)

    Time frame: Day 1 up to Day 42 (MAD)

    Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs

  3. Percentage of subjects with laboratory abnormalities

    Time frame: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)

  4. Number of subjects with change from baseline in vital signs

    Time frame: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)

    Number of subjects with change from baseline of blood pressure, pulse rate, and oral temperature

  5. Number of subjects with change from baseline in electrocardiogram (ECG) parameters

    Time frame: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)

Secondary outcomes

  1. Maximum Plasma concentration (Cmax)

    Time frame: Day 1 (SAD) or Day 1 and Day 14 (MAD)

    Maximum observed plasma concentration (Cmax)

  2. Time to reach plasma Cmax (Tmax)

    Time frame: Day 1 (SAD) or Day 1 and Day 14 (MAD)

    Time to reach maximum observed plasma concentration (Tmax)

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Day 1 up to Day 3 (SAD)

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    Time frame: Day 1 up to Day 3 (SAD)

    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).

  5. Dose normalized Cmax (Cmax(dn))

    Time frame: Day 1 (SAD) or Day 1 and Day 14 (MAD)

    Dose normalized maximum plasma concentration (Cmax(dn))

  6. Apparent Oral Clearance (CL/F)

    Time frame: Day 1 (SAD) or Day 14 (MAD)

    Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed and a quantitative measure of the rate at which the drug is removed from the blood.

  7. Apparent Volume of Distribution (Vz/F)

    Time frame: Day 1 (SAD) or Day 14 (MAD)

    Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

  8. Single dose and Multiple Dose PK half-life (t½)

    Time frame: Day 1 (SAD) or Day 14 (MAD)

    Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.

  9. Observed Accumulation Ratio for Cmax (Rac,Cmax)

    Time frame: MAD, Day 14

    Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose.

  10. Observed Accumulation Ratio for AUCτau (Rac, AUCτau)

    Time frame: MAD, Day 14

    Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCτau) from time 0-τau (Day 14) divided by AUC from time 0-τau (Day 1).

  11. Area Under the Curve From Time Zero to End of Dosing Interval (AUCτau)

    Time frame: Day 1 and Day 14 of MAD

    Area under the concentration curve from time 0 to end of dosing interval (AUCτau), where dosing interval is 12 hours.

  12. Minimum Observed Plasma Trough Concentration (Cmin)

    Time frame: Day 1 up to Day 14 of MAD

    Minimum plasma concentration over the dosing interval τau (12 hour) from first dose to last dose

  13. Multiple dose PK/AUCτau (dn)

    Time frame: Day 1 and Day 14 of MAD

    Dose normalized area under the curve over the dosing interval τau (12 hour) after the first and last dose (AUCτau (dn))

  14. Cumulative Amount of Drug Recovered Unchanged in Urine during dosing interval (Ae,τau)

    Time frame: MAD, Day 14

    Cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours (Ae,τau)

  15. Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τau (Ae,τau%)

    Time frame: MAD, Day 14

    Percent of dose recovered in urine as unchanged drug over the dosing interval (Ae,τau%)

  16. Renal Clearance (Clr)

    Time frame: MAD, Day 14

    Renal clearance calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae,τau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCτau), where dosing interval is 12 hours.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, STUDY TO ASSESS SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING ORAL DOSES OF PF-07054894 IN HEALTHY ADULT PARTICIPANTS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 14, 2020
Registry last updated
Jul 12, 2022

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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