A Multiple-Dose Study of LY3493269 in Healthy Participants

Healthy Clinical Trial

Official title:

An Open-Label, Multiple-Dose Study to Investigate the Pharmacokinetics of LY3493269 Oral Formulations Administered in a Fed or Fasted State in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05794243
• Other study ID #: 18360
• Secondary ID: J1X-MC-GZHI
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2023
• Est. completion date: June 20, 2023

Study information

• Verified date: August 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to conduct blood tests to measure how much LY3493269 is in the bloodstream and how the body handles and eliminates LY3493269 when administered orally as test compared to reference formulations in healthy participants in fed and/or fasted states. The study will also evaluate the safety and tolerability of LY3493269 in these participants. The study will last up to 43 days excluding the screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female participants who are overtly healthy as determined by medical evaluation
• Participants with body mass index (BMI) of 19.0 to 40.0 kilograms per meter squared (kg/m²)
• Males who agree to use highly effective/effective methods of contraception and only women not of child bearing potential may participate in the trial

Exclusion Criteria:

• Have a history of atopy (severe or multiple allergic manifestations) or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis)
• Have a significant history of or current CV (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, GI (including involving the liver, gallbladder or gallbladder surgery), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the IP; or of interfering with the interpretation of data.
• Have a mean supine HR less than 45 bpm or greater than 100 bpm from 2 assessments at screening.
• Have a mean supine systolic BP higher than 160 mmHg and a mean supine diastolic BP higher than 95 mmHg from 2 assessments at screening
• Have undergone any form of bariatric surgery.
• Have a history of GI bleeding, or gastric or duodenal ulcers.
• Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the ULN.
• Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
• Have evidence of significant active neuropsychiatric disease as determined by the investigator.
• Have been treated with prescription drugs that promote weight loss within 3 months prior to screening.
• Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have participated within the past 30 days of screening in a clinical study involving an IP; at least 5 half-lives or 30 days, whichever is longer, should have passed.
• Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis, such as a QTcF >450 msec for males and >470 msec for females, short PR interval (<120 msec), or PR interval >220 msec, second- or third-degree atrioventricular block, intraventricular conduction delay with QRS >120 msec, right bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome.
• Have serum AST or ALT >1.5x ULN or TBL >1.5x ULN.
• Show evidence of human immunodeficiency virus infection and/or positive human immunodeficiency virus antibodies.
• Show evidence of hepatitis C and/or positive hepatitis C antibody.
• Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3493269
Administered orally.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration-time curve (AUC) of LY3493269	PK: AUC of LY3493269	Predose up to 43 days postdose
Primary	PK: Maximum Observed Concentration (Cmax) of LY3493269	PK: Cmax of LY3493269	Predose up to 43 days postdose