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A Study to Investigate the Bioequivalence of Two Different Forms of Entrectinib (Forms A and C) Under Fasted Conditions in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03796013
Recruitment Status : Completed
First Posted : January 8, 2019
Results First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study aims to demonstrate similarities between two different forms of entrectinib (A and C) when administered under fasted conditions in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Entrectinib Form A Drug: Entrectinib Form C Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Way Crossover Study to Investigate the Bioequivalence of Entrectinib Polymorph Forms A and C Under Fasted Conditions in Healthy Subjects
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Entrectinib

Arm Intervention/treatment
Experimental: Form A to Form C Crossover
Participants first randomized to this arm will receive a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of each Period. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
Drug: Entrectinib Form A
Participants will receive a single oral dose of entrectinib form A under fasted conditions.

Drug: Entrectinib Form C
Participants will receive a single oral dose of entrectinib form C under fasted conditions.

Experimental: Form C to Form A Crossover
Participants first randomized to this arm will receive a single oral dose of entrectinib form C (test form) under fasted conditions on Day 1 of each Period. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib form A (reference form) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
Drug: Entrectinib Form A
Participants will receive a single oral dose of entrectinib form A under fasted conditions.

Drug: Entrectinib Form C
Participants will receive a single oral dose of entrectinib form C under fasted conditions.




Primary Outcome Measures :
  1. Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite [ Time Frame: At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days) ]
  2. Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite [ Time Frame: At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days]) ]
    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination
  • Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV)
  • Females must not be pregnant or breastfeeding, and females of childbearing potential will agree to use highly-effective contraception. Females of childbearing potential must also agree to refrain from donating eggs during the treatment period and for 6 weeks after the final dose of study drug
  • Males must agree to use contraception and to refrain from sperm donation from check-in (Day -1 of Period 1) to 90 days after the final dose of study drug

Exclusion Criteria:

  • History of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract
  • Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant. Ongoing chronic disorders which are not considered clinically significant are permissible providing they are stable
  • Clinically significant change in health status, as judged by the investigator, or any major illness within the 4 weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
  • Participation in any other clinical study involving an investigational medicinal product (IMP) or device within 30 days or 5 half-lives (if known), whichever is longer, before screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796013


Locations
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United States, Texas
Covance Research Unit - Dallas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Genentech, Inc.:
Study Protocol  [PDF] November 5, 2018
Statistical Analysis Plan  [PDF] January 31, 2019

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03796013    
Other Study ID Numbers: GP41049
First Posted: January 8, 2019    Key Record Dates
Results First Posted: March 9, 2020
Last Update Posted: March 9, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Entrectinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action