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

NCT04388878 | Completed Phase 1

• 2 other identifiers: C41510012020-000772-38
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• Percentage of subjects with laboratory abnormalities

  Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD)

• 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)

• 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 Outcomes (16)

• Maximum Plasma concentration (Cmax)

  Day 1 (SAD) or Day 1 and Day 14 (MAD)

• Time to reach plasma Cmax (Tmax)

  Day 1 (SAD) or Day 1 and Day 14 (MAD)

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

  Day 1 up to Day 3 (SAD)

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

  Day 1 up to Day 3 (SAD)

• Dose normalized Cmax (Cmax(dn))

  Day 1 (SAD) or Day 1 and Day 14 (MAD)

Study Arms (2)

PF-07054894

EXPERIMENTAL

Participants will receive single or multiple ascending doses of oral PF-07054894

Drug: PF-07054894

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo

Drug: Placebo

Interventions

PF-07054894 DRUG

Participants will receive oral ascending doses

PF-07054894

Placebo DRUG

Participants will receive matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Brussels Clinical Research Unit

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

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: July 27, 2020
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)