Study Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants
NCT04388878
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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.
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Descriptive Information | |||||
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Brief Title ICMJE | Study Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science | ||||
Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 64 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 29, 2021 | ||||
Estimated Primary Completion Date | June 29, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04388878 | ||||
Other Study ID Numbers ICMJE | C4151001 2020-000772-38 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |