Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment
NCT ID: NCT02873650
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2016-12-20
2019-04-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group 1 - Control group
dabrafenib
Single dose of 100 mg dabrafenib on Day 1
Group 2-Moderate hepatic impairment
dabrafenib
Single dose of 100 mg dabrafenib on Day 1
Group 3-Severe hepatic impairment
dabrafenib
Single dose of 100 mg dabrafenib on Day 1
Interventions
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dabrafenib
Single dose of 100 mg dabrafenib on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females must be of non-childbearing potential . All non-postmenopausal females must have a confirmed negative serum pregnancy
* Subjects in good health condition as determined by no clinically significant findings from medical history and physical examination.
* Body mass index (BMI) between ≥18.0 and ≤38.0 kg/m2, with body weight ≥ 50 kg and no more than 140 kg
* Laboratory values must be within normal limits (correction allowed) or considered clinically insignificant
* Do not participate in any other clinical trials with a BRAF or other RAF inhibitors
* Absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms and clinical laboratory determinations.
* Must match to at least one hepatic impairment subject by age, gender and bodyweight
* Confirmed hepatic disease
* Stable Child-Pugh status within 28 days prior to dosing.
Exclusion Criteria
* Significant acute illness within the two weeks prior to dosing
* History of immunodeficiency diseases, including a positive HIV
* History of malignancy of any organ system, treated or untreated, within 5 years
* Any prior history of keratoacanthoma and/or cutaneous squamous cell carcinoma
* A known diagnosis of any of the RASopathies, such as NF-1, Noonan syndrome, or related conditions.
* History of drug or alcohol abuse within the 6 months prior to dosing
* Smoking: urine cotinine levels below 500 ng/mL on Day -1.
* Use of drugs known to affect CYP3A4 and/or CYP2C8 including both (strong or moderate) inhibitors and inducers, within 7 days prior to dosing
* Administration of medications that prolong the QT interval within 4 weeks prior to dosing and until EOT.
* History or current diagnosis of cardiac disease indicating significant risk of safety
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs.
* Clinical evidence of liver disease or liver injury
* History or presence of renal impairment as indicated by abnormal creatinine or BUN values
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody
* Alcohol or drug abuse within one month prior to dosing or evidence of such
* History of liver transplantation at any time in the past and is on immunosuppressant therapy.
* Encephalopathy Grade 3 or worse within 28 days of dosing.
* History of surgical portosystemic shunt.
* Life expectancy ≤3 months
Other protocol-defined inclusion/exclusion may apply.
18 Years
75 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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American Institute of Research
Los Angeles, California, United States
Omega Research Consultants LLC
DeBary, Florida, United States
Hassman Research Institute
Berlin, New Jersey, United States
Wake Research Associates Oncology
Raleigh, North Carolina, United States
Countries
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Related Links
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Other Identifiers
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CDRB436A2107
Identifier Type: -
Identifier Source: org_study_id