CompletedNCT03023826Updated Apr 19, 2021Results posted

A Study of LY3202626 in Healthy Participants

A Phase 1 interventional study of LY3202626 (R-Fasting) and LY3202626 (T1-Fasting) in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in Singapore. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-19.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 26
Allocation: Randomized
Ages: 21 Years and older
Sex: All

Study summary

The purposes of this study are to determine:

If there are any differences in the way LY3202626 is handled by the body when taken in two different forms
Whether a high fat meal affects the way the body handles LY3202626
How well tolerated LY3202626 is

There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

The study will last about 50 days, not including screening.

Conditions studied

Healthy

In context

Lead sponsor

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.

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Are overtly healthy males or females, as determined by medical history and physical examination
Female participants must be of non-childbearing potential confirmed by medical history or menopause
Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion criteria

Exclusion Criteria:

Are investigative site personnel directly affiliated with this study and their immediate families
Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Have a history of head trauma with loss of consciousness within the last 5 years
Have known or ongoing psychiatric disorders

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 26 participants (actual)

Study arms

Experimental
LY3202626 (R-Fasting)
Single oral dose of LY3202626 (R) capsule under fasting conditions.
Drug: LY3202626 (R-Fasting)
Experimental
LY3202626 (T1-Fasting)
Single oral dose of LY3202626 (T1) tablet under fasting conditions.
Drug: LY3202626 (T1-Fasting)
Experimental
LY3202626 (T1-Fed)
Single oral dose of LY3202626 (T1) following a high fat breakfast.
Drug: LY3202626 (T1-Fed)

Interventions

DrugLY3202626 (R-Fasting)
Administered orally
DrugLY3202626 (T1-Fasting)
Administered orally
DrugLY3202626 (T1-Fed)
Administered orally

What researchers measure

Primary outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626
PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626
PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

Results

Posted Apr 19, 2021

Participant flow

Period 1

Participant flow — Period 1
Milestone	Sequence (ACB)	Sequence (CAB)	Sequence (BAC)	Sequence (ABC)	Sequence (BCA)	Sequence (CBA)
Started	4	4	5	4	4	5
Received at least one dose of study drug	4	4	5	4	4	5
Completed	4	4	5	4	3	5
Not completed	0	0	0	0	1	0
Withdrew: Withdrawal by subject	0	0	0	0	1	0

Period 2

Participant flow — Period 2
Milestone	Sequence (ACB)	Sequence (CAB)	Sequence (BAC)	Sequence (ABC)	Sequence (BCA)	Sequence (CBA)
Started	4	4	5	4	3	5
Completed	4	4	5	4	3	5
Not completed	0	0	0	0	0	0

Period 3

Participant flow — Period 3
Milestone	Sequence (ACB)	Sequence (CAB)	Sequence (BAC)	Sequence (ABC)	Sequence (BCA)	Sequence (CBA)
Started	4	4	5	4	3	5
Completed	4	4	5	4	3	5
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryPharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626

Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626

Time frame:: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Reported as:: Geometric mean · nanogram/milliliter (ng/mL)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
nanogram/milliliter (ng/mL)	12 mg LY3202626 (R-Fasting)	12 mg LY3202626 (T1-Fasting)	12 mg LY3202626 (T1-Fed)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626	27.9 ± 64	36.1 ± 45	39.4 ± 42

PrimaryPK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626

PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626

Time frame:: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Reported as:: Geometric mean · hour*nanogram/milliliter (h*ng/mL)

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626
hournanogram/milliliter (hng/mL)	12 mg LY3202626 (R-Fasting)	12 mg LY3202626 (T1-Fasting)	12 mg LY3202626 (T1-Fed)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626	540 ± 62	707 ± 45	702 ± 46

PrimaryPK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626

PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626

Time frame:: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Reported as:: Mean · h*ng/mL

PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626
h*ng/mL	12 mg LY3202626 (R-Fasting)	12 mg LY3202626 (T1-Fasting)	12 mg LY3202626 (T1-Fed)
PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626	531 ± 62	667 ± 47	691 ± 45

Adverse events

Collected over Baseline to End of Study (Up to 3 Months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
12 mg LY3202626 (R-Fasting)	0/25 (0%)	0/25 (0%)	8/25 (32%)
12 mg LY3202626 (T1-Fasting)	0/26 (0%)	0/26 (0%)	7/26 (26.9%)
12 mg LY3202626 (T1-Fed)	0/25 (0%)	0/25 (0%)	9/25 (36%)

Most frequent other events

Most frequent other events
Event	12 mg LY3202626 (R-Fasting)	12 mg LY3202626 (T1-Fasting)	12 mg LY3202626 (T1-Fed)
Vessel puncture site bruiseGeneral disorders	4/25	1/26	5/25
Catheter site bruiseGeneral disorders	1/25	1/26	3/25
Catheter site erythemaGeneral disorders	3/25	3/26	2/25
Catheter site pruritusGeneral disorders	1/25	1/26	2/25
Catheter site swellingGeneral disorders	2/25	1/26	0/25
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	0/25	2/26	0/25

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	All Participants
Mean	45.2 ± 11.7

Sex: Female, Male
Sex: Female, Male(Participants)	All Participants
Female	2
Male	24

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Participants
Hispanic or Latino	0
Not Hispanic or Latino	26
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	All Participants
American Indian or Alaska Native	0
Asian	24
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	1
More than one race	1
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(Participants)	All Participants
Singapore	26

Study locations

1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Singapore, 117597, Singapore

References and documents

Study documents

Study protocol · Sep 10, 2016
Statistical analysis plan · Jan 17, 2017

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03023826
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Jan 18, 2017
Start date: Jan 15, 2017
Primary completion: Apr 4, 2017
Completion: Apr 4, 2017
Results posted: Apr 19, 2021
Last update: Apr 19, 2021

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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