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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Multiple Dose Study of LY3502970 in Healthy Participants

NCTNCT05051566 (opens ClinicalTrials.gov in a new tab)Other id17783Other idJ2A-MC-GZGDOther idQSC202755Other id2020-005750-15
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
26 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Single masking
Countries
1 country

United Kingdom

Start
16 Sept 2021
Primary completion
4 Apr 2022
Completion
4 Apr 2022
First posted
21 Sept 2021
Last update posted
29 May 2026
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 1

    A Multiple Dose Study of LY3502970 in Healthy Participants

    NCT05051566

    16 Sept 2021 to 4 Apr 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 assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.

Interventions

  • LY3502970Drug
  • EsomeprazoleDrug

Arms2

  • Experimental

    Part A

    * Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 milligrams (mg), increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD) * Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).

  • Experimental

    Part B

    * Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI 40 mg Esomeprazole tablet first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK (pharmacokinetic) parameters were evaluated under these elevated gastric pH conditions

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Registry description

    Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

  2. Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Registry description

    Part A: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

  3. Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Registry description

    Part A: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

  4. Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Registry description

    Part B: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

  5. Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Registry description

    Part B: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

  6. Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Registry description

    Part B: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

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 hours post-dose (Days 24, 30 and 36)

Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

GroupValue (nanograms per milliliter (ng/mL))Spread
Part A (LY3502970)66.277.4
Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

GroupValue (nanogram*hours per milliliter (ng*h/mL))Spread
Part A (LY3502970)98866.9
Primary outcomeMedian· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

GroupValue (hours)
Part A (LY3502970)7.02
Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

GroupValue (ng/mL)Spread
Part B63.432.2
Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

GroupValue (ng*h/mL)Spread
Part B90325.3
Primary outcomeMedian· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

GroupValue (hours)
Part B8.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part A - 2 mg CapsulePart A participants who received 2 mg LY3502970 capsule were grouped in this arm.0 / 120 / 1211 / 12
Part A - 4 mg CapsulePart A participants who received 4 mg LY3502970 capsule were grouped in this arm.0 / 120 / 1211 / 12
Part A - 8 mg CapsulePart A participants who received 8 mg LY3502970 capsule were grouped in this arm.0 / 120 / 1211 / 12
Part A - 16 mg CapsulePart A participants who received 16 mg LY3502970 capsule were grouped in this arm.0 / 110 / 1111 / 11
Part A - 16 mg Prototype 1 TabletPart A participants who received 16 mg LY3502970 prototype 1 tablet were grouped in this arm.0 / 100 / 109 / 10
Part A - 16 mg Prototype 2 TabletPart A participants who received 16 mg LY3502970 prototype 2 tablet were grouped in this arm.0 / 100 / 108 / 10
Part B - 2 mg CapsulePart B participants who received 2 mg LY3502970 capsule were grouped in this arm.0 / 140 / 1413 / 14
Part B - 4 mg CapsulePart B participants who received 4 mg LY3502970 capsule were grouped in this arm.0 / 140 / 1412 / 14
Part B - 8 mg CapsulePart B participants who received 8 mg LY3502970 capsule were grouped in this arm.0 / 140 / 1413 / 14
Part B -16 mg Prototype 2 Tablet/FastedPart B participants who received 16 mg LY3502970 prototype 2 tablet in fasted stage were grouped in this arm.0 / 140 / 1412 / 14
Part B - 16 mg Prototype 2 Tablet/FedPart B participants who received 16 mg LY3502970 prototype 2 tablet in fed stage were grouped in this arm.0 / 120 / 128 / 12
Part B - 16 mg Prototype 2 Tablet + PPIPart B participants who received 16 mg LY3502970 prototype 2 tablet together with PPI Esomeprazole in fasted stage were grouped in this arm.0 / 120 / 128 / 12

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 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation. * Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²). Exclusion Criteria: * Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed * Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 2X ULN (Upper Limit of Normal) * Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study * Are women of child-bearing potential * Are women who are lactating

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