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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 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 postdose

Results posted on

2026-05-27

Participant Flow

Participant milestones

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

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

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 postdose

Population: 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

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 postdose

Population: 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

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 postdose

Population: 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

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

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

500 mg Clarithromycin Q12H

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

500 mg Clarithromycin Q12H + 3 mg LY3502970

Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60