A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04782076
Collaborator
Eli Lilly and Company (Industry)
36
1
1
2.4
15

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine the effect of selpercatinib on the levels of dabigatran in the blood stream and how long it takes the body to remove dabigatran. This study will also look at how safe and well-tolerated of dabigatran when administered in combination with selpercatinib in healthy participants. This study will last approximately 22 to 25 days.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers
Actual Study Start Date :
Mar 5, 2021
Actual Primary Completion Date :
May 17, 2021
Actual Study Completion Date :
May 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dabigatran + Selpercatinib

Dabigatran as single dose administered orally on Day 1 followed by a single dose of dabigatran coadministered with a single dose of selpercatinib on Day 8 orally.

Drug: Dabigatran
Administered orally.

Drug: Selpercatinib
Administered orally.
Other Names:
  • LY3527723
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran [Predose up to 72 hours post-dose on Days 1 and 8]

      PK: Cmax of Dabigatran

    2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Dabigatran [Predose up to 72 hours post-dose on Days 1 and 8]

      PK: AUC(0-inf) of Dabigatran

    Secondary Outcome Measures

    1. PK: Cmax of Selpercatinib [Predose up to 72 hours post-dose on Day 8]

      PK: Cmax of Selpercatinib

    2. PK: AUC(0-inf) of Selpercatinib [Predose up to 72 hours post-dose on Day 8]

      PK: AUC(0-inf) of Selpercatinib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Overtly healthy males or females, as determined by medical history, physical examination and vital signs.

    • Body mass index (BMI) within the range of 19 to 35 kilograms per meter squared (kg/m²)

    • Male participants are not required to adhere to contraceptive requirements and female participants of childbearing potential must agree to be either remain abstinent or stay in a same sex relationship without sexual relationships with males or must agree to use a highly effective method of contraception and who underwent bilateral salpingectomy. The Female participants not of childbearing potential are not required to use contraception.

    Exclusion Criteria:
    • Have a positive pregnancy test at screening or Day -1, where applicable

    • Are planning to become pregnant during the study or within 1 month of study completion

    • Are women who are lactating

    • Have known allergies to selpercatinib- or dabigatran-related compounds or any components of the formulation of selpercatinib or dabigatran, or history of significant atopy

    • Have a history of allergic reactions to medications or food products

    • Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator

    • Have known bleeding disorder including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder

    • Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF >450 msec on more than 1 ECG obtained during screening only

    • Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib

    • Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

    • Have an average weekly alcohol intake that exceeds 21 units per week (males ≤65 years old) and 14 units per week (females); 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirit(s)

    • Are smokers of more than 10 cigarettes or e-cigarettes, or 3 cigars or 3 pipes, per day

    • Consume excessive amounts of coffee, tea, cola, or other caffeinated beverages per day

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Clinical Research Inc Daytona Beach Florida United States 32117

    Sponsors and Collaborators

    • Loxo Oncology, Inc.
    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Loxo Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT04782076
    Other Study ID Numbers:
    • 17972
    • J2G-MC-JZJV
    First Posted:
    Mar 4, 2021
    Last Update Posted:
    Jul 16, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 16, 2021