Trial Outcomes & Findings for A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants (NCT NCT05573230)
NCT ID: NCT05573230
Last Updated: 2026-05-26
Results Overview
PK: AUC of LY3502970
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose
Results posted on
2026-05-26
Participant Flow
This is a 2-period single arm study with a washout period of at least 14 days between Period 1 and Period 2.
Participant milestones
| Measure |
Midazolam + Cyclosporine + LY3502970
Period 1: 200 μg Midazolam administered as oral solution (5mg/5 mL solution ampoule) on Days -1, followed by 3 mg LY3502970 capsule given orally on Day 1.
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.
|
|---|---|
|
Midazolam + LY3502970 (Period 1)
STARTED
|
32
|
|
Midazolam + LY3502970 (Period 1)
Received at Least One Dose of Study Drug
|
31
|
|
Midazolam + LY3502970 (Period 1)
COMPLETED
|
25
|
|
Midazolam + LY3502970 (Period 1)
NOT COMPLETED
|
7
|
|
Cyclosporine + LY3502970 (Period 2)
STARTED
|
25
|
|
Cyclosporine + LY3502970 (Period 2)
COMPLETED
|
21
|
|
Cyclosporine + LY3502970 (Period 2)
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Midazolam + Cyclosporine + LY3502970
Period 1: 200 μg Midazolam administered as oral solution (5mg/5 mL solution ampoule) on Days -1, followed by 3 mg LY3502970 capsule given orally on Day 1.
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.
|
|---|---|
|
Midazolam + LY3502970 (Period 1)
Adverse Event
|
4
|
|
Midazolam + LY3502970 (Period 1)
Withdrawal by Subject
|
1
|
|
Midazolam + LY3502970 (Period 1)
Physician Decision
|
2
|
|
Cyclosporine + LY3502970 (Period 2)
Adverse Event
|
1
|
|
Cyclosporine + LY3502970 (Period 2)
Withdrawal by Subject
|
3
|
Baseline Characteristics
A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Midazolam + Cyclosporine + LY3502970
n=31 Participants
Period 1: 200 μg Midazolam administered as oral solution (5mg/5 mL solution ampoule) on Days -1, 16, 19 followed by 3 mg LY3502970 capsule given orally on Day 1.
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.
|
|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 11.5 • n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
Singapore
|
31 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC of LY3502970
Outcome measures
| Measure |
LY3502970 (Reference)
n=21 Participants
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.
|
Cyclosporine + LY3502970 (Test)
n=10 Participants
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.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
|
332 nanogram * hour per milliliter (ng*hr/mL
Geometric Coefficient of Variation 39
|
857 nanogram * hour per milliliter (ng*hr/mL
Geometric Coefficient of Variation 51
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax of LY3502970
Outcome measures
| Measure |
LY3502970 (Reference)
n=21 Participants
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.
|
Cyclosporine + LY3502970 (Test)
n=11 Participants
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.
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970
|
13.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
18.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
Adverse Events
200 ug Midazolam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
3 mg LY3502970 (Reference)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
200 mg Cyclosporine BID + 200 ug Midazolam
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
200 mg Cyclosporine BID + 3 mg LY3502970 (Test)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
200 mg Cyclosporine
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
200 ug Midazolam
n=31 participants at risk
200 ug midazolam administered as oral solution \[5 milligrams (mg) per milliliter (mL) solution ampoule\] on -1 Day
|
3 mg LY3502970 (Reference)
n=31 participants at risk
3 mg LY3502970 capsule given orally on Day 1 in Period 1.
|
200 mg Cyclosporine BID + 200 ug Midazolam
n=24 participants at risk
200 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
|
200 mg Cyclosporine BID + 3 mg LY3502970 (Test)
n=24 participants at risk
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.
|
200 mg Cyclosporine
n=25 participants at risk
Single oral dose 200 mg (2 - 100 mg) cyclosporine capsules on Day 20.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 3 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.0%
3/25 • Number of events 4 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
35.5%
11/31 • Number of events 12 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
41.7%
10/24 • Number of events 10 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.0%
1/25 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 3 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
35.5%
11/31 • Number of events 12 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
37.5%
9/24 • Number of events 9 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.0%
1/25 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
41.9%
13/31 • Number of events 30 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
54.2%
13/24 • Number of events 35 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
20.0%
5/25 • Number of events 11 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site bruise
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.1%
5/31 • Number of events 5 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 5 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
20.0%
5/25 • Number of events 5 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site erythema
|
6.5%
2/31 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
9.7%
3/31 • Number of events 4 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 4 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.0%
3/25 • Number of events 3 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.0%
1/25 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 4 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.0%
4/25 • Number of events 5 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site swelling
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 4 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.0%
2/25 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
6.5%
2/31 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.0%
1/25 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 3 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
32.0%
8/25 • Number of events 8 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.9%
4/31 • Number of events 5 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
6.5%
2/31 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.1%
5/31 • Number of events 5 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
45.8%
11/24 • Number of events 11 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.0%
3/25 • Number of events 3 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.0%
2/25 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.1%
5/31 • Number of events 6 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/25 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.1%
5/31 • Number of events 5 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 4 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
16.0%
4/25 • Number of events 4 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
3.2%
1/31 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.0%
3/25 • Number of events 3 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/31 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
12.0%
3/25 • Number of events 3 • Baseline up to 76 days
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place