Trial Outcomes & Findings for A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants (NCT NCT05469126)
NCT ID: NCT05469126
Last Updated: 2026-05-27
Results Overview
PK: AUC(0-∞) of LY3502970 is reported.
COMPLETED
PHASE1
26 participants
Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose
2026-05-27
Participant Flow
Participant milestones
| Measure |
3 mg LY3502970 (Day 1) and 500 mg Clarithromycin Q12H + 3 mg LY3502970 (Day 21)
Participants received below
Period 1:
Day 1: Single dose of 3 milligram (mg) LY3502970 administered orally on Day 1.
Participants were fasted overnight and remained in a fasted state with no access to food for 4 hours after taking the study drug.
Period 2:
Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H).
Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.
Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later
There was a washout period of at least 14 days between Period 1 and Period 2.
|
|---|---|
|
LY3502970 Alone (Period 1)
STARTED
|
26
|
|
LY3502970 Alone (Period 1)
Received at Least One Dose of Study Drug
|
26
|
|
LY3502970 Alone (Period 1)
COMPLETED
|
21
|
|
LY3502970 Alone (Period 1)
NOT COMPLETED
|
5
|
|
Clarithromycin + LY3502970 (Period 2)
STARTED
|
21
|
|
Clarithromycin + LY3502970 (Period 2)
Received at Least One Dose of Study Drug
|
21
|
|
Clarithromycin + LY3502970 (Period 2)
COMPLETED
|
21
|
|
Clarithromycin + LY3502970 (Period 2)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
3 mg LY3502970 (Day 1) and 500 mg Clarithromycin Q12H + 3 mg LY3502970 (Day 21)
Participants received below
Period 1:
Day 1: Single dose of 3 milligram (mg) LY3502970 administered orally on Day 1.
Participants were fasted overnight and remained in a fasted state with no access to food for 4 hours after taking the study drug.
Period 2:
Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H).
Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.
Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later
There was a washout period of at least 14 days between Period 1 and Period 2.
|
|---|---|
|
LY3502970 Alone (Period 1)
Adverse Event
|
5
|
Baseline Characteristics
A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Participants
n=26 Participants
Participants received below
Period 1:
Day 1: Single dose of 3 mg LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state with no access to food for 4 hours after taking the study drug.
Period 2:
Day 15 to 31: 500 mg of clarithromycin administered orally Q12H.
Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.
Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later
There was a washout period of at least 14 days between Period 1 and Period 2.
|
|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 11.8 • n=51 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
Singapore
|
26 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdosePopulation: All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).
PK: AUC(0-∞) of LY3502970 is reported.
Outcome measures
| Measure |
LY3502970 (Day 1)
n=16 Participants
Period 1: Participants received a single 3 mg dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug.
|
Clarithromycin + LY3502970 (Day 21)
n=12 Participants
Period 2: Participants received 500 mg of clarithromycin administered orally Q12H from Days 15 to 31. On day 21, one hour after the 500 mg of clarithromycin was administered, a single dose of 3 mg of LY3502970 was administered orally.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970
|
380 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
1380 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
PRIMARY outcome
Timeframe: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdosePopulation: All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of tmax.
PK: AUC(0-tlast) of LY3502970 is reported.
Outcome measures
| Measure |
LY3502970 (Day 1)
n=16 Participants
Period 1: Participants received a single 3 mg dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug.
|
Clarithromycin + LY3502970 (Day 21)
n=12 Participants
Period 2: Participants received 500 mg of clarithromycin administered orally Q12H from Days 15 to 31. On day 21, one hour after the 500 mg of clarithromycin was administered, a single dose of 3 mg of LY3502970 was administered orally.
|
|---|---|---|
|
PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970
|
333 ng*h/ mL
Geometric Coefficient of Variation 37
|
1270 ng*h/ mL
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdosePopulation: All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of tmax.
PK: Cmax of LY3502970 is reported.
Outcome measures
| Measure |
LY3502970 (Day 1)
n=16 Participants
Period 1: Participants received a single 3 mg dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug.
|
Clarithromycin + LY3502970 (Day 21)
n=12 Participants
Period 2: Participants received 500 mg of clarithromycin administered orally Q12H from Days 15 to 31. On day 21, one hour after the 500 mg of clarithromycin was administered, a single dose of 3 mg of LY3502970 was administered orally.
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970
|
15.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
30.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
Adverse Events
3 mg LY3502970
500 mg Clarithromycin Q12H
500 mg Clarithromycin Q12H + 3 mg LY3502970
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 mg LY3502970
n=26 participants at risk
Participants received a single 3 mg dose of LY3502970 administered orally on Day 1.
Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug.
|
500 mg Clarithromycin Q12H
n=21 participants at risk
Participants received 500 mg of clarithromycin every 12 hours (Q12H) administered orally from Days 15 to 31.
|
500 mg Clarithromycin Q12H + 3 mg LY3502970
n=21 participants at risk
Participants received 500 mg clarithromycin followed by 3 mg LY3502970 administered orally on day 21.
Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later.
|
|---|---|---|---|
|
Gastrointestinal disorders
Eructation
|
7.7%
2/26 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
4.8%
1/21 • Number of events 1 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Faeces hard
|
3.8%
1/26 • Number of events 1 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
4.8%
1/21 • Number of events 1 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
9.5%
2/21 • Number of events 3 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal distension
|
30.8%
8/26 • Number of events 8 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
23.8%
5/21 • Number of events 5 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
9.5%
2/21 • Number of events 4 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
1/26 • Number of events 4 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
9.5%
2/21 • Number of events 3 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
14.3%
3/21 • Number of events 5 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Nausea
|
34.6%
9/26 • Number of events 9 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
33.3%
7/21 • Number of events 8 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
42.3%
11/26 • Number of events 44 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
47.6%
10/21 • Number of events 35 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
General disorders
Catheter site bruise
|
7.7%
2/26 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
19.0%
4/21 • Number of events 5 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
General disorders
Catheter site erythema
|
0.00%
0/26 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
28.6%
6/21 • Number of events 7 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
General disorders
Catheter site pain
|
0.00%
0/26 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
19.0%
4/21 • Number of events 5 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
General disorders
Catheter site swelling
|
3.8%
1/26 • Number of events 1 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
14.3%
3/21 • Number of events 3 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
General disorders
Fatigue
|
7.7%
2/26 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
4.8%
1/21 • Number of events 1 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
General disorders
Vessel puncture site bruise
|
7.7%
2/26 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
9.5%
2/21 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
13/26 • Number of events 13 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
47.6%
10/21 • Number of events 10 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
33.3%
7/21 • Number of events 7 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/26 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
14.3%
3/21 • Number of events 3 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/26 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
9.5%
2/21 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Headache
|
34.6%
9/26 • Number of events 10 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
28.6%
6/21 • Number of events 6 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Somnolence
|
7.7%
2/26 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/26 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
9.5%
2/21 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/21 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/26 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
9.5%
2/21 • Number of events 2 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
4.8%
1/21 • Number of events 1 • Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60