A Phase I, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of LY3526318, and to Investigate the Effect of LY3526318 on Metformin and Simvastatin Pharmacokinetics in Healthy Male Japanese Participants

This is a study of LY3526318 in healthy male Japanese. The main purposes of this study are to:
Assess how safe and well tolerated LY3526318 is when given by mouth.
Measure how LY3526318 affects the kidney and the liver. The study will be conducted in three parts (Part A, Part B, Part C). Participants may only enroll in one part. After screening, the study will last from one to two weeks, depending on part.

Start Date22 Nov 2022

Sponsor / Collaborator

Eli Lilly & Co.

NCT05177094 / CompletedPhase 2

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Diabetic Peripheral Neuropathic Pain

The purpose of this study is to test the safety and efficacy of study drug LY3526318 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.

Start Date26 Jan 2022

Sponsor / Collaborator

Eli Lilly & Co.

NCT05086289 / CompletedPhase 2

Randomized Placebo-controlled Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Chronic Low Back Pain

The purpose of this study is to test whether LY3526318 is efficacious and safe in relieving chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.

Start Date25 Oct 2021

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with LY-3526318

100 Translational Medicine associated with LY-3526318

100 Patents (Medical) associated with LY-3526318

Literatures (Medical) associated with LY-3526318

01 Nov 2023·Clinical Pharmacology & Therapeutics

TRPA1 Antagonist LY3526318 Inhibits the Cinnamaldehyde‐Evoked Dermal Blood Flow Increase: Translational Proof of Pharmacology

Article

Author: Collins, Emily Catherine ; Wilke, August ; Laenen, Jolien ; Marynissen, Heleen ; Dreesen, Erwin ; Shahabi, Shahram ; Blockeel, Anthony James ; Broad, Lisa M ; Bamps, Dorien ; Johnson, Kirk W ; de Hoon, Jan ; Van Hecken, Anne ; Phillips, Keith G

Transient receptor potential Ankyrin 1 (TRPA1) is an ion channel expressed by sensory neurons, where it mediates pain signaling. Consequently, it has emerged as a promising target for novel analgesics, yet, to date, no TRPA1 antagonists have been approved for clinical use. In the present translational study, we utilized dermal blood flow changes evoked by TRPA1 agonist cinnamaldehyde as a target engagement biomarker to investigate the in vivo pharmacology of LY3526318, a novel TRPA1 antagonist. In rats, LY3526318 (1, 3, and 10 mg/kg, p.o.) dose‐dependently reduced the cutaneous vasodilation typically observed following topical application of 10% v/v cinnamaldehyde. The inhibition was significant at the site of cinnamaldehyde application and also when including an adjacent area of skin. Similarly, in a cohort of 16 healthy human volunteers, LY3526318 administration (10, 30, and 100 mg, p.o.) dose‐dependently reduced the elevated blood flow surrounding the site of 10% v/v cinnamaldehyde application, with a trend toward inhibition at the site of application. Comparisons between both species reveal that the effects of LY3526318 on the cinnamaldehyde‐induced dermal blood flow are greater in rats relative to humans, even when adjusting for cross‐species differences in potency of the compound at TRPA1. Exposure‐response relationships suggest that a greater magnitude response may be observed in humans if higher antagonist concentrations could be achieved. Taken together, these results demonstrate that cinnamaldehyde‐evoked changes in dermal blood flow can be utilized as a target engagement biomarker for TRPA1 activity and that LY3526318 antagonizes the ion channel both in rats and humans.

100 Deals associated with LY-3526318

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Pain	Phase 2	US	Eli Lilly & Co.	30 Jan 2020
Chronic Pain	Phase 2	PR	Eli Lilly & Co.	30 Jan 2020
Diabetic peripheral neuropathic pain	Phase 2	PR	Eli Lilly & Co.	30 Jan 2020
Diabetic peripheral neuropathic pain	Phase 2	US	Eli Lilly & Co.	30 Jan 2020
Low Back Pain	Phase 2	PR	Eli Lilly & Co.	30 Jan 2020
Low Back Pain	Phase 2	US	Eli Lilly & Co.	30 Jan 2020
Osteoarthritis, Knee	Phase 2	PR	Eli Lilly & Co.	30 Jan 2020
Osteoarthritis, Knee	Phase 2	US	Eli Lilly & Co.	30 Jan 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05177094 (CTgov)	Phase 2	Chronic Pain \| Diabetic peripheral neuropathic pain	155	Placebo	zudafoumvi(fqidsittah) = kfklfecsou wdyprmsxac (wompieydbx, xaqkdywior - kudydaoaxr) View more	-	22 Nov 2023
NCT05086289 (CTgov)	Phase 2	Low Back Pain \| Chronic Pain	159	Placebo	tgdzzkinys(ydruqgwnmd) = ztqvmbisda wewhnwgknr (ajpkdjkdsx, juxopommcm - bblogjwrgk) View more	-	05 Oct 2023
NCT05080660 (CTgov)	Phase 2	Chronic Pain \| Osteoarthritis, Knee	160	Placebo	ioxkxbpemg(tbnwhycghz) = ncfuzakizm oofdbcijio (goglurffwy, aciwfgfcan - idohgfezpi) View more	-	06 Sep 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

LY-3526318

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation