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A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03796260
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Entrectinib Test Formulation (F1) Drug: Entrectinib Reference Formulation (F06) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 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 Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Subjects
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 27, 2019
Estimated Study Completion Date : February 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: F1 to F06 Crossover
Participants first randomized to this arm will receive a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F06 (reference formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
Drug: Entrectinib Test Formulation (F1)
Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.

Drug: Entrectinib Reference Formulation (F06)
Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.

Experimental: F06 to F1 Crossover
Participants first randomized to this arm will receive a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F1 (test formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days).
Drug: Entrectinib Test Formulation (F1)
Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.

Drug: Entrectinib Reference Formulation (F06)
Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.




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

Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline through the end of study (approximately 8 weeks) ]


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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): NCT03796260


Contacts
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Contact: Reference Study ID Number: GP41048 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
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United States, Florida
Covance Research Unit - Daytona Recruiting
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03796260     History of Changes
Other Study ID Numbers: GP41048
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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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