HealthyPhase 1NCT03099148

A Study of LY3337641 in Healthy Participants

A Phase 1 study testing Reference Formulation (R), LY3337641 (T1) and LY3337641 (T2) in people with Healthy, run by Eli Lilly and Company at 2 sites in Singapore.

Completed

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

Official record

Search all trials

Trial summary

The purposes of this study are to determine: If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested. How a high-fat meal affects the amount of LY3337641 in the blood/body. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Reference Formulation (R), LY3337641 (T1) and LY3337641 (T2)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesSingapore
Study dates: 4 Apr 2017to 31 May 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 to 65 years
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
Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
Have clinical laboratory test results within normal reference range for the population or investigative site
Are able and willing to give signed informed consent

Who cannot join

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 significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), 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 used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Singapore, 117597
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

Other trials in Singapore

About this study

Official title: Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects

The purposes of this study are to determine:

If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested.
How a high-fat meal affects the amount of LY3337641 in the blood/body.
How safe and well tolerated LY3337641 is.

The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).

This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.

Conditions: Healthy
Being tested: Reference Formulation (R), LY3337641 (T1), LY3337641 (T2)

What participants receive

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

Reference Formulation (R)Drug
Administered PO
LY3337641 (T1)Drug
20 mg PO
LY3337641 (T2)Drug
20 mg PO

Study groups in NCT03099148
Study group	Role	What they receive
LY3337641 (R-fasted)	Experimental	A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods. Receives: Drug: Reference Formulation (R)
LY3337641 (T1-fasted)	Experimental	A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods. Receives: Drug: LY3337641 (T1)
LY3337641 (T1-fed)	Experimental	A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods. Receives: Drug: LY3337641 (T1)
LY3337641 (T2-fasted)	Experimental	A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods. Receives: Drug: LY3337641 (T2)

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 LY3337641
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Measured: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3337641
Measured: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose

Timeline

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

4 Apr 201731 May 2017

First posted4 Apr 2017
Study start4 Apr 2017
Primary completion31 May 2017
Study completion31 May 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: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03099148
Sponsor's protocol ID: 16298
Other IDs: I8K-MC-JPDF
Status last verified: Oct 2023
First submitted: 30 Mar 2017
Last updated: 17 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects
ClinicalTrials.gov ID: NCT03099148
Acronym / sponsor ID: 16298
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 4 Apr 2017 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 31 May 2017 (actual)
First posted: 4 Apr 2017 (actual)
Results: Posted 17 Oct 2023

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 amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested.
How a high-fat meal affects the amount of LY3337641 in the blood/body.
How safe and well tolerated LY3337641 is.

The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).

This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
LY3337641 (R-fasted)	Experimental	Drug: Reference Formulation (R)A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods.
LY3337641 (T1-fasted)	Experimental	Drug: LY3337641 (T1)A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods.
LY3337641 (T1-fed)	Experimental	Drug: LY3337641 (T1)A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods.
LY3337641 (T2-fasted)	Experimental	Drug: LY3337641 (T2)A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Are overtly healthy males or females, as determined by medical history and physical examination
Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
Have clinical laboratory test results within normal reference range for the population or investigative site
Are able and willing to give signed informed consent

Key exclusion criteria (4 listed)

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 significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), 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 used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

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
Reference Formulation (R)Administered PO	Drug	LY3337641 (R-fasted)
LY3337641 (T1)20 mg PO	Drug	LY3337641 (T1-fasted), LY3337641 (T1-fed)
LY3337641 (T2)20 mg PO	Drug	LY3337641 (T2-fasted)

Primary outcome

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Time frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
Time frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3337641

Results and safety

Results posted to the registry on 17 Oct 2023, 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 ADBC	7	7
Sequence BACD	7	7
Sequence CBDA	7	7
Sequence DCAB	8	8

Primary outcome: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641

Time frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Reference Formulation (R-fasted) n = 28	LY3337641 (T1-fasted) n = 29	LY3337641 (T1-fed) n = 27	LY3337641 (T2-fasted) n = 27
Value	66.7 (40)	64.9 (41)	56.8 (44)	65.5 (35)

Population analysed: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641

Measure	Reference Formulation (R-fasted) n = 28	LY3337641 (T1-fasted) n = 29	LY3337641 (T1-fed) n = 27	LY3337641 (T2-fasted) n = 27
Value	373 (44)	371 (47)	351 (42)	361 (43)

Population analysed: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.

Adverse events

Time frame: 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reference Formulation (R-fasted)	0 of 28 (0%)	6 of 28 (21.4%)	0 of 28
LY3337641 (T1-fasted)	0 of 29 (0%)	4 of 29 (13.8%)	0 of 29
LY3337641 (T1-fed)	0 of 27 (0%)	5 of 27 (18.5%)	0 of 27
LY3337641 (T2-fasted)	0 of 27 (0%)	2 of 27 (7.4%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Reference Formulation (R), LY3337641 (T1) and LY3337641 (T2) in people with Healthy, run by Eli Lilly and Company at 2 sites 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 4 inclusion and 4 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 17 Oct 2023). 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 LY3337641 (time frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose). The study lists 2 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 NCT03099148.

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 17 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.