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Phase 1 Completed N=28 Randomized Treatment

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

Healthy Volunteers
Source: ClinicalTrials.gov NCT03796013 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite — 18500; 16600; 3610; 3070 nmol*h/L

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite
18500; 16600; 3610; 3070
PRIMARY
Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite
796; 726; 138; 114
SECONDARY
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
7.1; 0

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03796013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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