Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

NCTNCT05573230Other id18506Other idJ2A-MC-GZGL

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 32 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Singapore
Start: 17 Oct 2022
Primary completion: 17 Jan 2023
Completion: 17 Jan 2023
First posted: 10 Oct 2022
Last update posted: 26 May 2026
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024

Ph 1
A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants
NCT05573230
17 Oct 2022 to 17 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant.

Interventions

MidazolamDrug
LY3502970Drug
CyclosporineDrug

Arms2

Experimental
Midazolam + LY3502970
Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1.
Experimental
Cyclosporine + Midazolam + LY3502970
Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20.

Primary outcomes2

Outcomes the sponsor listed as primary.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose
Registry description
PK: AUC of LY3502970
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose
Registry description
PK: Cmax of LY3502970

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970

Group	Value (nanogram * hour per milliliter (ng*hr/mL)	Spread
LY3502970 (Reference)	332	39
Cyclosporine + LY3502970 (Test)	857	51

Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose

PK: Maximum Observed Concentration (Cmax) of LY3502970

Group	Value (nanogram per milliliter (ng/mL))	Spread
LY3502970 (Reference)	13.9	48
Cyclosporine + LY3502970 (Test)	18.4	36

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
200 ug Midazolam200 ug midazolam administered as oral solution \[5 milligrams (mg) per milliliter (mL) solution ampoule\] on -1 Day	0 / 31	0 / 31	4 / 31
3 mg LY3502970 (Reference)3 mg LY3502970 capsule given orally on Day 1 in Period 1.	0 / 31	0 / 31	28 / 31
200 mg Cyclosporine BID + 200 ug Midazolam200 mg (2 - 100 mg) cyclosporine capsules administered twice daily (BID) on Days 15 through 19 in combination with 200 µg midazolam administered as oral solution on Days 16 and 19	0 / 24	0 / 24	18 / 24
200 mg Cyclosporine BID + 3 mg LY3502970 (Test)200 mg (2 - 100 mg) cyclosporine capsules administered twice daily (BID) on Days 15 through 19 in combination with 3 mg LY3502970 on Day 17.	0 / 24	0 / 24	22 / 24
200 mg CyclosporineSingle oral dose 200 mg (2 - 100 mg) cyclosporine capsules on Day 20.	0 / 25	0 / 25	20 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation * Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²) * Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants * Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential Exclusion Criteria: * Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Participants who regularly use known drugs of abuse * Women who are lactating and who are of child-bearing potential * Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

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