A Phase 1 interventional study of LY2409021 in Healthy, sponsored by Eli Lilly and Company. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-29.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of LY2409021 capsule in one of three study periods.
Drug: LY2409021
Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods.
Drug: LY2409021
Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods.
Drug: LY2409021
Single oral dose of LY2409021 capsule in one of two study periods.
Drug: LY2409021
Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.
Drug: LY2409021
Administered orally
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021
Time frame: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
PK: Maximum Plasma Concentration (Cmax) of LY2409021
Time frame: Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
This study was designed to have two parts. During Part A, decision was made to terminate the study. Participants in Part A were allowed to complete the study. Part B was not conducted.
| Milestone | LY2409021 Capsules/T2/T3 (Part A) | LY2409021 T2/Capsules/T3 (Part A) | LY2409021 T3/T2/Capsules (Part A) | LY2409021 T3/Capsules/T2 (Part A) | LY2409021 T2/T3/Capsules (Part A) | LY2409021 Capsules/T3/T2 (Part A) |
|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 3 |
| Received ly2409021 | 3 | 3 | 3 | 3 | 3 | 3 |
| Washout | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | LY2409021 Capsules/T2/T3 (Part A) | LY2409021 T2/Capsules/T3 (Part A) | LY2409021 T3/T2/Capsules (Part A) | LY2409021 T3/Capsules/T2 (Part A) | LY2409021 T2/T3/Capsules (Part A) | LY2409021 Capsules/T3/T2 (Part A) |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 3 | 3 | 3 | 3 |
| Received ly2409021 | 2 | 3 | 3 | 3 | 3 | 3 |
| Washout | 2 | 3 | 3 | 3 | 3 | 3 |
| Completed | 2 | 3 | 2 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | LY2409021 Capsules/T2/T3 (Part A) | LY2409021 T2/Capsules/T3 (Part A) | LY2409021 T3/T2/Capsules (Part A) | LY2409021 T3/Capsules/T2 (Part A) | LY2409021 T2/T3/Capsules (Part A) | LY2409021 Capsules/T3/T2 (Part A) |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 1 | 3 | 2 | 3 |
| Received ly2409021 | 2 | 3 | 1 | 3 | 2 | 3 |
| Washout | 2 | 3 | 1 | 3 | 2 | 3 |
| Completed | 2 | 3 | 1 | 3 | 2 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| nanograms x hours/milliliters (ng•h/mL | LY2409021 Capsules (Part A) | LY2409021 T2 (Part A) | LY2409021 T3 (Part A) |
|---|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021 | 56400 ± 17 | 55700 ± 24 | 59100 ± 15 |
| ng/mL | LY2409021 Capsules (Part A) | LY2409021 T2 (Part A) | LY2409021 T3 (Part A) |
|---|---|---|---|
| PK: Maximum Plasma Concentration (Cmax) of LY2409021 | 724 ± 18 | 718 ± 30 | 760 ± 20 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2409021 Capsules (Part A) | — | 0/15 (0%) | 4/15 (26.7%) |
| LY2409021 T2 (Part A) | — | 0/17 (0%) | 1/17 (5.9%) |
| LY2409021 T3 (Part A) | — | 0/17 (0%) | 4/17 (23.5%) |
| Event | LY2409021 Capsules (Part A) | LY2409021 T2 (Part A) | LY2409021 T3 (Part A) |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/15 | 0/17 | 0/17 |
| Upper respiratory tract infectionInfections and infestations | 1/15 | 1/17 | 0/17 |
| Neck painMusculoskeletal and connective tissue disorders | 1/15 | 0/17 | 0/17 |
| HeadacheNervous system disorders | 1/15 | 0/17 | 0/17 |
| InsomniaPsychiatric disorders | 1/15 | 0/17 | 0/17 |
| Abdominal distensionGastrointestinal disorders | 0/15 | 0/17 | 1/17 |
| Abdominal tendernessGastrointestinal disorders | 0/15 | 0/17 | 1/17 |
| AstheniaGeneral disorders | 0/15 | 0/17 | 1/17 |
| FatigueGeneral disorders | 0/15 | 0/17 | 1/17 |
| Alanine aminotransferase increasedInvestigations | 0/15 | 0/17 | 1/17 |
All participants who received at least 1 formulation of LY2409021.
| Age, Continuous(years) | LY2409021 (Part A) |
|---|---|
| Mean | 44.4 ± 13.0 |
| Sex: Female, Male(Participants) | LY2409021 (Part A) |
|---|---|
| Female | 4 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | LY2409021 (Part A) |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | LY2409021 (Part A) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | LY2409021 (Part A) |
|---|---|
| United States | 18 |
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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