Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment

Phase 1

Terminated

• Conditions: Hepatic Impairment
• Interventions: Drug: dabrafenib

• Registration Number: NCT02873650
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2016-12-20
• Primary Completion: 2018-10-12
• Study Completion: 2019-04-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2-Moderate hepatic impairment	dabrafenib	-
Group 1 - Control group	dabrafenib	-
Group 3-Severe hepatic impairment	dabrafenib	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	Predose through 96 hours postdose
Area under the curve (AUFinf)	Predose through 96 hours postdose
Elimination half-life (T1/2)	Predose through 96 hours postdose
Area under the curve (AUClast)	Predose through 96 hours postdose
Volume of distribution (Vz/F)	Predose through 96 hours postdose
Systemic drug clearance (CL/F)	Predose through 96 hours postdose
Time to reach maximum concentration (Tmax)	Predose through 96 hours postdose
Terminal elimination rate (Lambda_z)	Predose through 96 hours postdose

Secondary Outcome Measures

Name	Time	Method
Number of subjects with abnormal body temperature related to study drug	Time of study drug administration through 30 days postdose
Number of subjects with abnormal lab values related to study drug	Time of study drug administration through 30 days postdose
Number of subjects with abnormal blood pressure related to study drug	Time of study drug administration through 30 days postdose
Number of subjects with abnormal pulse rate related to study drug	Time of study drug administration through 30 days postdose
Number of subjects with adverse events	Time of study drug administration through 30 days postdose
Number of subjects with abnormal respiratory rate related to study drug	Time of study drug administration through 30 days postdose
Changes in electrocardiogram (ECG)	Time of study drug administration through 30 days postdose

Trial Locations

Locations (4)

American Institute of Research; 🇺🇸 Los Angeles, California, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Wake Research Associates Oncology; 🇺🇸 Raleigh, North Carolina, United States

Omega Research Consultants LLC; 🇺🇸 DeBary, Florida, United States