HealthyPhase 1NCT03023826

A Study of LY3202626 in Healthy Participants

A Phase 1 study testing LY3202626 (R-Fasting), LY3202626 (T1-Fasting) and LY3202626 (T1-Fed) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3202626 (R-Fasting), LY3202626 (T1-Fasting) and LY3202626 (T1-Fed)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteSingapore
Study dates: 15 Jan 2017to 4 Apr 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product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

Trial locations and contacts

1 site in 1 country.

Singapore1 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

Other trials in Singapore

About this study

Official title: Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626

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: Healthy
Being tested: LY3202626 (R-Fasting), LY3202626 (T1-Fasting), LY3202626 (T1-Fed)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3202626 (R-Fasting)Drug
Administered orally
LY3202626 (T1-Fasting)Drug
Administered orally
LY3202626 (T1-Fed)Drug
Administered orally

Study groups in NCT03023826
Study group	Role	What they receive
LY3202626 (R-Fasting)	Experimental	Single oral dose of LY3202626 (R) capsule under fasting conditions. Receives: Drug: LY3202626 (R-Fasting)
LY3202626 (T1-Fasting)	Experimental	Single oral dose of LY3202626 (T1) tablet under fasting conditions. Receives: Drug: LY3202626 (T1-Fasting)
LY3202626 (T1-Fed)	Experimental	Single oral dose of LY3202626 (T1) following a high fat breakfast. Receives: Drug: LY3202626 (T1-Fed)

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
Measured: 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
Measured: 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
Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20174 Apr 2017

First posted18 Jan 2017 (estimated)
Study start15 Jan 2017
Primary completion4 Apr 2017
Study completion4 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03023826
Sponsor's protocol ID: 15567
Other IDs: I7X-MC-LLCE
Status last verified: Mar 2021
First submitted: 16 Jan 2017
Last updated: 19 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626
ClinicalTrials.gov ID: NCT03023826
Acronym / sponsor ID: 15567
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 15 Jan 2017
Primary completion: 4 Apr 2017 (actual)
Study completion: 4 Apr 2017 (actual)
First posted: 18 Jan 2017 (estimated)
Results: Posted 19 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

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

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3202626 (R-Fasting)Administered orally	Drug	LY3202626 (R-Fasting)
LY3202626 (T1-Fasting)Administered orally	Drug	LY3202626 (T1-Fasting)
LY3202626 (T1-Fed)Administered orally	Drug	LY3202626 (T1-Fed)

Primary outcome

Pharmacokinetics (PK): 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
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
PK: 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 is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626
PK: 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
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

Results and safety

Results posted to the registry on 19 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence (ACB)	4	4
Sequence (CAB)	4	4
Sequence (BAC)	5	5
Sequence (ABC)	4	4
Sequence (BCA)	4	3
Sequence (CBA)	5	5

Primary outcome: Pharmacokinetics (PK): 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. Geometric mean (Standard Deviation). Unit: nanogram/milliliter (ng/mL)

Measure	12 mg LY3202626 (R-Fasting) n = 25	12 mg LY3202626 (T1-Fasting) n = 25	12 mg LY3202626 (T1-Fed) n = 25
Value	27.9 (64)	36.1 (45)	39.4 (42)

Population analysed: All randomized participants who received at least one dose and who had evaluable PK data.

Primary outcome: PK: 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. Geometric mean (Standard Deviation). Unit: hour*nanogram/milliliter (h*ng/mL)

Measure	12 mg LY3202626 (R-Fasting) n = 25	12 mg LY3202626 (T1-Fasting) n = 24	12 mg LY3202626 (T1-Fed) n = 25
Value	540 (62)	707 (45)	702 (46)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: 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. Mean (Standard Deviation). Unit: h*ng/mL

Measure	12 mg LY3202626 (R-Fasting) n = 25	12 mg LY3202626 (T1-Fasting) n = 25	12 mg LY3202626 (T1-Fed) n = 25
Value	531 (62)	667 (47)	691 (45)

Population analysed: All randomized participants who received at least one dose of study drug and who had evaluable PK data.

Adverse events

Time frame: Baseline to End of Study (Up to 3 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
12 mg LY3202626 (R-Fasting)	0 of 25 (0%)	8 of 25 (32%)	0 of 25
12 mg LY3202626 (T1-Fasting)	0 of 26 (0%)	7 of 26 (26.9%)	0 of 26
12 mg LY3202626 (T1-Fed)	0 of 25 (0%)	9 of 25 (36%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3202626 (R-Fasting), LY3202626 (T1-Fasting) and LY3202626 (T1-Fed) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03023826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.