HealthyPhase 1NCT04782076

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

A Phase 1 study testing Dabigatran and Selpercatinib in people with Healthy, run by Loxo Oncology, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Dabigatran and Selpercatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 5 Mar 2021to 17 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Inc
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers

Conditions: Healthy
Being tested: Dabigatran, Selpercatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DabigatranDrug
Administered orally.
SelpercatinibDrug
Also called LY3527723
Administered orally.

Study groups in NCT04782076
Study group	Role	What they receive
Dabigatran + Selpercatinib	Experimental	Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) selpercatinib on Day 8. There was a washout period of 7 days between dosing on Days 1 and 8. Receives: Drug: Dabigatran; Drug: Selpercatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran
PK: Cmax of Dabigatran
Measured: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran
PK: AUC(0-inf) of Dabigatran
Measured: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose

Secondary outcomes (3)

PK: Cmax of Selpercatinib
PK: Cmax of Selpercatinib
Measured: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: AUC(0-inf) of Selpercatinib
PK: AUC(0-inf) of Selpercatinib
Measured: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Selpercatinib
PK: Tmax of Selpercatinib
Measured: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 202117 May 2021

First posted4 Mar 2021
Study start5 Mar 2021
Primary completion17 May 2021
Study completion17 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04782076
Sponsor's protocol ID: 17972
Other IDs: J2G-MC-JZJV
Status last verified: May 2024
First submitted: 2 Mar 2021
Last updated: 24 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers
ClinicalTrials.gov ID: NCT04782076
Acronym / sponsor ID: 17972
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Loxo Oncology, Inc.Industry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 5 Mar 2021 (actual)
Primary completion: 17 May 2021 (actual)
Study completion: 17 May 2021 (actual)
First posted: 4 Mar 2021 (actual)
Results: Posted 24 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dabigatran + Selpercatinib	Experimental	Drug: Dabigatran, Drug: SelpercatinibParticipants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) selpercatinib on Day 8. There was a washout period of 7 days between dosing on Days 1 and 8.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DabigatranAdministered orally.	Drug	Dabigatran + Selpercatinib
SelpercatinibAlso: LY3527723Administered orally.	Drug	Dabigatran + Selpercatinib

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran
Time frame: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose
PK: Cmax of Dabigatran
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran
Time frame: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: AUC(0-inf) of Dabigatran

3 secondary outcomes

PK: Cmax of Selpercatinib
Time frame: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: AUC(0-inf) of Selpercatinib
Time frame: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Selpercatinib
Time frame: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose

Results and safety

Results posted to the registry on 24 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran + Selpercatinib	36	35

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran

Time frame: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose. Geometric least squares mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Dabigatran n = 36	Selpercatinib + Dabigatran n = 35
Value	192 (41)	276 (36)

Dabigatran vs Selpercatinib + Dabigatran: LS Mean Difference (Final Values): 1.43 (90% CI 1.33 to 1.55), Mixed Models Analysis

Population analysed: All participants who received at least one dose of dabigatran and had evaluable PK.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran

Time frame: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	Dabigatran n = 36	Selpercatinib + Dabigatran n = 35
Value	1650 (42)	2290 (37)

Dabigatran vs Selpercatinib + Dabigatran: LS Mean Difference (Final Values): 1.38 (90% CI 1.30 to 1.46), Mixed Models Analysis

Population analysed: All participants who received at least one dose of dabigatran had evaluable PK.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 25 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
150 mg Dabigatran	0 of 36 (0%)	0 of 36 (0%)	0 of 36
150 mg Dabigatran + 160 mg Selpercatinib	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dabigatran and Selpercatinib in people with Healthy, run by Loxo Oncology, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran (time frame: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04782076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.