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

NCT03796013 | Completed Phase 1 Results FDA Drug

• 1 other identifier: GP41049
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite

  At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days)

• Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite

  At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days)

Secondary Outcomes (1)

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days])

Study Arms (2)

Form A to Form C Crossover

EXPERIMENTAL

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; Drug: Entrectinib Form C

Form C to Form A Crossover

EXPERIMENTAL

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; Drug: Entrectinib Form C

Interventions

Entrectinib Form A DRUG

Participants will receive a single oral dose of entrectinib form A under fasted conditions.

Form A to Form C Crossover; Form C to Form A Crossover

Entrectinib Form C DRUG

Participants will receive a single oral dose of entrectinib form C under fasted conditions.

Form A to Form C Crossover; Form C to Form A Crossover

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Covance Research Unit - Dallas

Dallas, Texas, 75247, United States

Location

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: January 10, 2019
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: March 9, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-02

Locations

US (1)