HealthyPhase 1NCT05338502

Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants

A Phase 1 study testing Selpercatinib, Ranitidine and Omeprazole in people with Healthy, run by Eli Lilly and Company 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

Search all trials

Trial summary

The main purpose of this study is to learn about how H2 antagonist (ranitidine) and proton pump inhibitor (PPI) (omeprazole) affect Selpercatinib in healthy participants. Information about safety and tolerability will be collected. The study will last up to about 9 weeks, inclusive of screening period. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Selpercatinib, Ranitidine and Omeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 8 Jul 2019to 3 Sep 2019
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Who cannot join

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit, Inc.
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: An Open-Label, 3-Period, Fixed Sequence Study to Evaluate the Effect of an H2 Antagonist and a Proton Pump Inhibitor on the Single Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects

Conditions: Healthy
Being tested: Selpercatinib, Ranitidine, Omeprazole

What participants receive

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

SelpercatinibDrug
Also called LY3527723, LOXO-292
Administered orally.
RanitidineDrug
Administered orally.
OmeprazoleDrug
Administered orally.

Study groups in NCT05338502
Study group	Role	What they receive
160 milligram (mg) Selpercatinib	Experimental	Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1). Receives: Drug: Selpercatinib
150 mg Ranitidine dosed with 160 mg Selpercatinib	Experimental	Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12). Receives: Drug: Selpercatinib; Drug: Ranitidine
40 mg Omeprazole dosed with 160 mg Selpercatinib	Experimental	Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23). Receives: Drug: Selpercatinib; Drug: Omeprazole

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
PK: AUC0-t of Selpercatinib. The analysis of variance (ANOVA) model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric least squares (LS) means and the difference between treatment geometric LS means, as well as their corresponding 90% confidence intervals (CIs). The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
PK: AUC0-inf of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of Selpercatinib
PK: %AUCextrap of Selpercatinib
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Maximum Observed Plasma Concentration (Cmax) of Selpercatinib
PK: Cmax of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Time of Maximum Observed Concentration (Tmax) of Selpercatinib
PK: Tmax of Selpercatinib
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Apparent Volume of Distribution (Vz/F)
PK: Vz/F of Selpercatinib
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
PK: CL/F of Selpercatinib
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Apparent Terminal Elimination Half-life (t½) of Selpercatinib
PK: t½ of Selpercatinib
Measured: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3

Timeline

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

8 Jul 20193 Sep 2019

First posted21 Apr 2022
Study start8 Jul 2019
Primary completion3 Sep 2019
Study completion3 Sep 2019

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.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05338502
Sponsor's protocol ID: 17574
Other IDs: J2G-OX-JZJL, LOXO-RET-19075
Status last verified: Aug 2024
First submitted: 19 Apr 2022
Last updated: 30 Oct 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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, 3-Period, Fixed Sequence Study to Evaluate the Effect of an H2 Antagonist and a Proton Pump Inhibitor on the Single Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05338502
Acronym / sponsor ID: 17574
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 8 Jul 2019 (actual)
Primary completion: 3 Sep 2019 (actual)
Study completion: 3 Sep 2019 (actual)
First posted: 21 Apr 2022 (actual)
Results: Posted 30 Oct 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
160 milligram (mg) Selpercatinib	Experimental	Drug: SelpercatinibParticipants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
150 mg Ranitidine dosed with 160 mg Selpercatinib	Experimental	Drug: Selpercatinib, Drug: RanitidineParticipants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
40 mg Omeprazole dosed with 160 mg Selpercatinib	Experimental	Drug: Selpercatinib, Drug: OmeprazoleParticipants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male or female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Key exclusion criteria (5 listed)

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2

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
SelpercatinibAlso: LY3527723, LOXO-292Administered orally.	Drug	150 mg Ranitidine dosed with 160 mg Selpercatinib, 160 milligram (mg) Selpercatinib, 40 mg Omeprazole dosed with 160 mg Selpercatinib
RanitidineAdministered orally.	Drug	150 mg Ranitidine dosed with 160 mg Selpercatinib
OmeprazoleAdministered orally.	Drug	40 mg Omeprazole dosed with 160 mg Selpercatinib

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: AUC0-t of Selpercatinib. The analysis of variance (ANOVA) model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric least squares (LS) means and the difference between treatment geometric LS means, as well as their corresponding 90% confidence intervals (CIs). The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: AUC0-inf of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
PK: Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of Selpercatinib
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: %AUCextrap of Selpercatinib
PK: Maximum Observed Plasma Concentration (Cmax) of Selpercatinib
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Cmax of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
PK: Time of Maximum Observed Concentration (Tmax) of Selpercatinib
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Tmax of Selpercatinib
PK: Apparent Volume of Distribution (Vz/F)
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: Vz/F of Selpercatinib
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: CL/F of Selpercatinib
PK: Apparent Terminal Elimination Half-life (t½) of Selpercatinib
Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
PK: t½ of Selpercatinib

Results and safety

Results posted to the registry on 30 Oct 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
160 mg Selpercatinib	20	20
150 mg Ranitidine Dosed With 160 mg Selpercatinib	0	0
40 mg Omeprazole Dosed With 160 mg Selpercatinib	0	0

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib

Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanograms per milliliter(h*ng/mL)

Measure	160 mg Selpercatinib n = 20	150 mg Ranitidine Dosed With 160 mg Selpercatinib n = 17	40 mg Omeprazole Dosed With 160 mg Selpercatinib n = 17
Value	21600 (31.4)	19100 (31.9)	21000 (27.4)

160 mg Selpercatinib vs 150 mg Ranitidine Dosed With 160 mg Selpercatinib: Geometric Least Squares Mean (LSM) Ratio: 0.900 (90% CI 0.797 to 1.02), ANOVA
160 mg Selpercatinib vs 40 mg Omeprazole Dosed With 160 mg Selpercatinib: Geometric LS Mean Ratio: 0.990 (90% CI 0.876 to 1.12), ANOVA

Population analysed: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for AUC0-t.

Primary outcome: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib

Measure	160 mg Selpercatinib n = 20	150 mg Ranitidine Dosed With 160 mg Selpercatinib n = 19	40 mg Omeprazole Dosed With 160 mg Selpercatinib n = 17
Value	21800 (31.2)	19900 (33.5)	21100 (27.4)

160 mg Selpercatinib vs 150 mg Ranitidine Dosed With 160 mg Selpercatinib: Geometric LS Mean Ratio: 0.932 (90% CI 0.829 to 1.05), ANOVA
160 mg Selpercatinib vs 40 mg Omeprazole Dosed With 160 mg Selpercatinib: Geometric LS Mean Ratio: 1.00 (90% CI 0.888 to 1.13), ANOVA

Population analysed: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for AUC0-inf.

Primary outcome: PK: Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of Selpercatinib

Time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3. Median (Full Range). Unit: percentage of (%) of AUCextrap

Measure	160 mg Selpercatinib n = 20	150 mg Ranitidine Dosed With 160 mg Selpercatinib n = 19	40 mg Omeprazole Dosed With 160mg Selpercatinib n = 17
Value	0.337 (0.136 to 3.00)	0.818 (0.137 to 2.02)	0.612 (0.103 to 1.59)

Population analysed: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for %AUCextrap.

Primary outcome: PK: Maximum Observed Plasma Concentration (Cmax) of Selpercatinib

Measure	160 mg Selpercatinib n = 20	150 mg Ranitidine Dosed With 160 mg Selpercatinib n = 19	40 mg Omeprazole Dosed With 160 mg Selpercatinib n = 17
Value	1650 (58.4)	1330 (67.8)	1220 (63.4)

160 mg Selpercatinib vs 150 mg Ranitidine Dosed With 160 mg Selpercatinib: Geometric LS Mean Ratio: 0.818 (90% CI 0.680 to 0.985), ANOVA
160 mg Selpercatinib vs 40 mg Omeprazole Dosed With 160 mg Selpercatinib: Geometric LS Mean Ratio: 0.782 (90% CI 0.645 to 0.949), ANOVA

Population analysed: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for Cmax.

Adverse events

Time frame: Baseline through Day 37. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
160 mg Selpercatinib	0 of 20 (0%)	5 of 20 (25%)	0 of 20
150 mg Ranitidine Dosed With 160 mg Selpercatinib	0 of 20 (0%)	11 of 20 (55%)	0 of 20
40 mg Omeprazole Dosed With 160 mg Selpercatinib	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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 Selpercatinib, Ranitidine and Omeprazole in people with Healthy, run by Eli Lilly and Company 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 5 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 30 Oct 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 30 Oct 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): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib (time frame: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3). The study lists 8 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 NCT05338502.

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 30 Oct 2024.