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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388878
• Other study ID #: C4151001
• Secondary ID: 2020-000772-38
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2020
• Est. completion date: June 21, 2022

Study information

• Verified date: July 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07054894
Participants will receive oral ascending doses
• Placebo
Participants will receive matching placebo

Locations

Country	Name	City	State
Belgium	Brussels Clinical Research Unit	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs following Single ascending dose (SAD)	Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs	Day 1 up to Day 28 (SAD)
Primary	AEs following multiple ascending dose (MAD)	Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs	Day 1 up to Day 42 (MAD)
Primary	Percentage of subjects with laboratory abnormalities		Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
Primary	Number of subjects with change from baseline in vital signs	Number of subjects with change from baseline of blood pressure, pulse rate, and oral temperature	Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
Primary	Number of subjects with change from baseline in electrocardiogram (ECG) parameters		Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)
Secondary	Maximum Plasma concentration (Cmax)	Maximum observed plasma concentration (Cmax)	Day 1 (SAD) or Day 1 and Day 14 (MAD)
Secondary	Time to reach plasma Cmax (Tmax)	Time to reach maximum observed plasma concentration (Tmax)	Day 1 (SAD) or Day 1 and Day 14 (MAD)
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Day 1 up to Day 3 (SAD)
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8).	Day 1 up to Day 3 (SAD)
Secondary	Dose normalized Cmax (Cmax(dn))	Dose normalized maximum plasma concentration (Cmax(dn))	Day 1 (SAD) or Day 1 and Day 14 (MAD)
Secondary	Apparent Oral Clearance (CL/F)	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.	Day 1 (SAD) or Day 14 (MAD)
Secondary	Apparent Volume of Distribution (Vz/F)	Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	Day 1 (SAD) or Day 14 (MAD)
Secondary	Single dose and Multiple Dose PK half-life (t½)	Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.	Day 1 (SAD) or Day 14 (MAD)
Secondary	Observed Accumulation Ratio for Cmax (Rac,Cmax)	Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose.	MAD, Day 14
Secondary	Observed Accumulation Ratio for AUCtau (Rac, AUCtau)	Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCtau) from time 0-tau (Day 14) divided by AUC from time 0-tau (Day 1).	MAD, Day 14
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours.	Day 1 and Day 14 of MAD
Secondary	Minimum Observed Plasma Trough Concentration (Cmin)	Minimum plasma concentration over the dosing interval tau (12 hour) from first dose to last dose	Day 1 up to Day 14 of MAD
Secondary	Multiple dose PK/AUCtau (dn)	Dose normalized area under the curve over the dosing interval tau (12 hour) after the first and last dose (AUCtau (dn))	Day 1 and Day 14 of MAD
Secondary	Cumulative Amount of Drug Recovered Unchanged in Urine during dosing interval (Ae,tau)	Cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours (Ae,tau)	MAD, Day 14
Secondary	Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau (Ae,tau%)	Percent of dose recovered in urine as unchanged drug over the dosing interval (Ae,tau%)	MAD, Day 14
Secondary	Renal Clearance (Clr)	Renal clearance calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae,tau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.	MAD, Day 14

External Links

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