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HMG-CoA Reductase Inhibitor
Rosuvastatin + Selpercatinib for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose up to 72 hours post-dose
Awards & highlights
Study Summary
This trial will test how selpercatinib affects levels of rosuvastatin in healthy people, and how safe and tolerable the combination is. It will last about 26 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose up to 72 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to 72 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Rosuvastatin + SelpercatinibExperimental Treatment2 Interventions
Rosuvastatin administered orally on day 1 followed by rosuvastatin administered with selpercatinib on day 5 orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
2019
Completed Phase 4
~3150
Selpercatinib
2021
Completed Phase 1
~600
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,889 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,648 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken or plan to take any over-the-counter or prescription medications, including vitamins and herbal supplements, within 14 days before the study.Your body mass index (BMI) should be between 19.0 and 32.0 kg/m².You are allergic to selpercatinib or rosuvastatin.
Research Study Groups:
This trial has the following groups:- Group 1: Rosuvastatin + Selpercatinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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