Phase 1
Completed N=14
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT03796260 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite — 44000; 44900; 14400; 15000 nmol*h/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite |
44000; 44900; 14400; 15000 | — |
| PRIMARY Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite |
41200; 42100; 11600; 12600 | — |
| PRIMARY Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite |
1870; 2000; 427; 487 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
28.6; 21.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT03796260). 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.