臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 02, 2024
Last modified on	Oct. 02, 2024
Trial ID	jRCT2071240067

Scientific Title	A Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of LY4065967, to Evaluate the Effect of LY4065967 on the Pharmacokinetics of Rosuvastatin, and to Assess Regional Absorption of LY4065967 in Healthy Japanese Participants (J4X-JE-LWCA)
Public Title	A Study of LY4065967 in Healthy Japanese Participants (J4X-JE-LWCA)

Contact for Scientific Queries	Name	Wakayama Naohiko
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com
Contact for Public Queries	Name	Trial Guide Call Center
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 10, 2024
Actual date of first enrollment
Target sample size		69
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	- Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination - Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2) - Have a body weight of: - >= 40 kilograms (kg) for individuals assigned female at birth - >= 50 kg for individuals assigned male at birth
	Exclusion Criteria	- Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation - Have an abnormality in the 12-lead echocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study - Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may hamper participation in the study - Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test - Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antigen and/or antibodies. - Show evidence of hepatitis B and/or positive hepatitis B surface antigen - Show evidence of syphilis or have a positive syphilis test. - Have an abnormal blood pressure (supine) as determined by the investigator - Are pregnant or intend to become pregnant or to breastfeed during the study. - Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission - Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator - Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes - Are unwilling to comply with the dietary restrictions required for this study
	Age Minimum	18age old over
	Age Maximum	55age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy
Intervention(s)		DRUG: LY4065967 Administered orally DRUG: Placebo Administered orally DRUG: Rosuvastatin Administered orally [Study Arms] Experimental: LY4065967 Part A A single dose of LY4065967 administered orally Interventions: Drug: LY4065967 Placebo Comparator: Placebo Part A Placebo administered orally Interventions: Drug: Placebo Experimental: LY4065967 Part B Multiple doses of LY4065967 administered orally Interventions: Drug: LY4065967 Placebo Comparator: Placebo Part B Placebo administered orally Interventions: Drug: Placebo Experimental: LY4065967 Part C LY4065967 administered orally Interventions: Drug: LY4065967 Experimental: LY4065967 and Rosuvastatin Part D LY4065967 and Rosuvastatin administered orally Interventions: Drug: LY4065967 Drug: Rosuvastatin
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Part A: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration [ Time Frame: Baseline to 7 Days ] Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module Part B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration [ Time Frame: Baseline to 12 Days ] Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 [ Time Frame: Predose on Day 1 Through 48 Hours Post-Dose ] Part C: PK: Cmax of LY4065967 Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967 [ Time Frame: Predose on Day 1 Through 48 Hours Post-Dose ] Part C: PK: AUC of LY4065967 Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin[ Time Frame:Predose on Day 1 Through 72 Hours Post-Dose ] Part D: PK: Cmax of Rosuvastatin Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin[ Time Frame:Predose on Day 1 Through 72 Hours Post-Dose ] Part D: PK: AUC of Rosuvastatin
Secondary Outcome(s)

Primary Sponsor	Eli Lilly Japan K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka City, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Sept. 19, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06594159
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	none