Clinical trial NCT04388878: Study Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: AEs following Single ascending dose (SAD)
timeFrame: Day 1 up to Day 28 (SAD)
measure: AEs following multiple ascending dose (MAD)
timeFrame: Day 1 up to Day 42 (MAD)
measure: Percentage of subjects with laboratory abnormalities
timeFrame: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
measure: Number of subjects with change from baseline in vital signs
timeFrame: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
measure: Number of subjects with change from baseline in electrocardiogram (ECG) parameters
timeFrame: Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
Secondary outcomes:
measure: Maximum Plasma concentration (Cmax)
timeFrame: Day 1 (SAD) or Day 1 and Day 14 (MAD)
measure: Time to reach plasma Cmax (Tmax)
timeFrame: Day 1 (SAD) or Day 1 and Day 14 (MAD)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Day 1 up to Day 3 (SAD)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: Day 1 up to Day 3 (SAD)
measure: Dose normalized Cmax (Cmax(dn))
timeFrame: Day 1 (SAD) or Day 1 and Day 14 (MAD)
measure: Apparent Oral Clearance (CL/F)
timeFrame: Day 1 (SAD) or Day 14 (MAD)
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Day 1 (SAD) or Day 14 (MAD)
measure: Single dose and Multiple Dose PK half-life (t½)
timeFrame: Day 1 (SAD) or Day 14 (MAD)
measure: Observed Accumulation Ratio for Cmax (Rac,Cmax)
timeFrame: MAD, Day 14
measure: Observed Accumulation Ratio for AUCτau (Rac, AUCτau)
timeFrame: MAD, Day 14
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCτau)
timeFrame: Day 1 and Day 14 of MAD
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: Day 1 up to Day 14 of MAD
measure: Multiple dose PK/AUCτau (dn)
timeFrame: Day 1 and Day 14 of MAD
measure: Cumulative Amount of Drug Recovered Unchanged in Urine during dosing interval (Ae,τau)
timeFrame: MAD, Day 14
measure: Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τau (Ae,τau%)
timeFrame: MAD, Day 14
measure: Renal Clearance (Clr)
timeFrame: MAD, Day 14
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brussels Clinical Research Unit
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: