Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

NCTNCT05469126Other id18507Other idJ2A-MC-GZGM

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 26 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Singapore
Start: 1 Aug 2022
Primary completion: 3 Nov 2022
Completion: 3 Nov 2022
First posted: 21 Jul 2022
Last update posted: 27 May 2026
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

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

20222023

Ph 1
A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants
NCT05469126
1 Aug 2022 to 3 Nov 2022

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 clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant.

Interventions

LY3502970Drug
ClarithromycinDrug

Arms2

Experimental
LY3502970 alone (Period 1)
Participants received a single 3 milligram (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.
Experimental
Clarithromycin + LY3502970 (Period 2)
Participants received below: 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

Primary outcomes3

Outcomes the sponsor listed as primary.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970
Time frame · 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
Registry description
PK: AUC(0-∞) of LY3502970 is reported.
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
Time frame · 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
Registry description
PK: AUC(0-tlast) of LY3502970 is reported.
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame · 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
Registry description
PK: Cmax of LY3502970 is reported.

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 least squares mean· 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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970

Group	Value (nanogramhour per milliliter (nghr/mL))	Spread
LY3502970 (Day 1)	380	40
Clarithromycin + LY3502970 (Day 21)	1380	31

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

Group	Value (ng*h/ mL)	Spread
LY3502970 (Day 1)	333	37
Clarithromycin + LY3502970 (Day 21)	1270	30

PK: Maximum Observed Concentration (Cmax) of LY3502970

Group	Value (nanograms per milliliter (ng/mL))	Spread
LY3502970 (Day 1)	15.4	38
Clarithromycin + LY3502970 (Day 21)	30.4	30

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
3 mg LY3502970Participants 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.	0 / 26	0 / 26	23 / 26
500 mg Clarithromycin Q12HParticipants received 500 mg of clarithromycin every 12 hours (Q12H) administered orally from Days 15 to 31.	0 / 21	0 / 21	9 / 21
500 mg Clarithromycin Q12H + 3 mg LY3502970Participants 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.	0 / 21	0 / 21	21 / 21

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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