A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2019-08-09

Brief Summary

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This study will evaluate the bioavailability, palatability, safety and tolerability of entrectinib in healthy volunteers. Part 1 of the study will explore the performance of entrectinib multi-particle formulation. Part 2 will evaluate the effect of drug substance particle size on entrectinib bioavailability.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Participants will be randomly assigned to one of the three treatment sequences (T1T2R, T2RT1, RT1T2). In each treatment sequences, participants will cross-over to three periods taking different formulations of entrectinib. Entrectinib will be administered as a single 600 milligram (mg) oral dose under fed condition in three different formulations. Test formulation 1 (T1): film-coated mini-tablet; Test formulation 2 (T2): film-coated mini-tablet; Reference formulation (R): hard capsule.

Group Type EXPERIMENTAL

Entrectinib 600 mg (T1)

Intervention Type DRUG

Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets

Entrectinib 600 mg (T2)

Intervention Type DRUG

Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets

Entrectinib 200 mg (R)

Intervention Type DRUG

Reference formulation (R): entrectinib hard capsules

Part 2

Participants will be randomly assigned to one of the two treatment sequences (TR, RT). In each treatment sequences, participants will cross-over to two periods taking different formulations of entrectinib. Entrectinib will be administered as a single 200 mg oral dose under fasted condition in two different formulations. Test formulation (T): hydroxypropyl methylcellulose (HPMC) capsule; Reference formulation (R): hard capsule.

Group Type EXPERIMENTAL

Entrectinib 200 mg (R)

Intervention Type DRUG

Reference formulation (R): entrectinib hard capsules

Entrectinib 200 mg (T)

Intervention Type DRUG

Test formulation (T): entrectinib HPMC capsules

Interventions

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Entrectinib 600 mg (T1)

Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets

Intervention Type DRUG

Entrectinib 600 mg (T2)

Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets

Intervention Type DRUG

Entrectinib 200 mg (R)

Reference formulation (R): entrectinib hard capsules

Intervention Type DRUG

Entrectinib 200 mg (T)

Test formulation (T): entrectinib HPMC capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2), inclusive, and weighing \>/=50 kg.
* Agreement to comply with measures to prevent pregnancy and restrictions on egg and sperm donation

Exclusion Criteria

* Women of childbearing potential, women who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of entrectinib or have a pregnant partner
* A clinical significant medical history of gastrointestinal surgery (e.g., gastric bypass) or other gastrointestinal disorder (e.g., malabsorption syndrome) 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
* Clinically significant change in health status, or any major illness, or clinically significant acute infection or febrile illness
* Use of moderate or potent inhibitors or inducers of CYP P450 3A4 enzyme or P-gp transporter, or use of other prohibited medications
* Participation in any other clinical study involving an investigational medicinal product (IMP) or device
* A positive test result for hepatitis B, hepatitis C (HCV), or human immunodeficiency virus (HIV)
* Current smokers and those who have smoked, or users of e-cigarettes and nicotine replacement products within the last 12 months
* Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes