A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
NCT04193436
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Male and female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the Screening visit:
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
- Any condition possibly affecting drug absorption (eg, prior bariatric surgery,
gastrectomy, ileal resection).
(Participants who have undergone cholecystectomy and/or appendectomy are eligible for this
study as long as the surgery occurred more than 6 months prior to Screening)..
- At Screening, participants with a positive result for human immunodeficiency virus
(HIV) antibodies, as assessed by sponsor identified central laboratory, with a single
repeat permitted to assess eligibility, if needed.
- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behaviour or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.
- Use of prior/concomitant therapies.
- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives preceding the first dose of investigational
product used in this study (whichever is longer).
- Participants with known prior participation (ie, randomized and received at least 1
dose of investigational product) in a study involving PF 06835919.
- A positive urine drug test, for illicit drugs, and/or a positive breath alcohol test
at Screening. However, participants who have been medially prescribed opiates/opiods
or benzodiazepines and report the use of these drugs to the investigator at the
screening visit will be allowed to participate.
- Male participants with partners who are currently pregnant.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing and until the follow-up contact.
- History of sensitivity to heparin or heparin induced thrombocytopenia, only if heparin
is used to flush intravenous catheters used during serial blood collections.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of the protocol.
- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.
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Descriptive Information | |||||
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Brief Title ICMJE | A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT | ||||
Official Title ICMJE | A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT | ||||
Brief Summary | The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: PF-06835919 25 mg
PF-06835919 in 25 mg oral tablet will be administered on Day 1 | ||||
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 | 24 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 28, 2021 | ||||
Estimated Primary Completion Date | September 28, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
(Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening)..
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium, Czechia, Slovakia | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04193436 | ||||
Other Study ID Numbers ICMJE | C1061013 HEPATIC IMPAIRMENT ( Other Identifier: Alias Study Number ) 2019-003480-21 ( 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 | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |