Healthy VolunteersPhase 1NCT01354496

A Study of LY2409021 Formulations and the Effect of Food

A Phase 1 study testing LY2409021 Reference Form, LY2409021 Test-Med Formulation (medium particle size) and LY2409021 Test-High Formulation (high particle size) in people with Healthy Volunteers, 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 compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food. The study will be conducted in 2 cohorts. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY2409021 Reference Form, LY2409021 Test-Med Formulation (medium particle size) and LY2409021 Test-High Formulation (high particle size)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteSingapore
Study dates: Apr 2011to Oct 2011
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

Must be healthy male or a healthy female who cannot become pregnant
Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
The veins must be suitable for easy blood collection
Must be willing to be available for the whole study and be willing to follow study procedures

Who cannot join

Were in another new drug or medical research study in the last 30 days
Have previously taken part in this study or any other study with LY2409021
Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
Electrocardiogram (ECG) readings are not suitable for the study
Are infected with hepatitis B

Show all 14Show fewer

Are infected with human immunodeficiency disease virus (HIV)
Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
Have a history of drug or alcohol abuse
Have donated 450 milliliters (mL) or more of blood in the last 3 months
Are unwilling or unable to comply with dietary requirements/restrictions during the study
The study doctor thinks the participant should not participate for any other reasons

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your person physician.
Singapore

Other trials in Singapore

About this study

Official title: LY2409021 Formulation Bridging and Food Effect Study

The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.

There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.

Conditions: Healthy Volunteers
Being tested: LY2409021 Reference Form, LY2409021 Test-Med Formulation (medium particle size), LY2409021 Test-High Formulation (high particle size), LY2409021 Test-Low Formulation (low particle size)
Keywords: Healthy Volunteers, Bioavailability

What participants receive

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

LY2409021 Reference FormDrug
Administered orally
LY2409021 Test-Med Formulation (medium particle size)Drug
Administered orally
LY2409021 Test-High Formulation (high particle size)Drug
Administered orally
LY2409021 Test-Low Formulation (low particle size)Drug
Administered orally

Study groups in NCT01354496
Study group	Role	What they receive
Cohort 1 - LY2409021 reference form	Experimental	A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state Receives: Drug: LY2409021 Reference Form
Cohort 1 - LY2409021 medium test form fed	Experimental	Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal Receives: Drug: LY2409021 Test-Med Formulation (medium particle size)
Cohort 1 - LY2409021 medium test form fasted	Experimental	Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state Receives: Drug: LY2409021 Test-Med Formulation (medium particle size)
Cohort 2 - LY2409021 low test form fasted	Experimental	Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state Receives: Drug: LY2409021 Test-Low Formulation (low particle size)
Cohort 2 - LY2409021 medium test form fasted	Experimental	Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state Receives: Drug: LY2409021 Test-Med Formulation (medium particle size)
Cohort 2 - LY2409021 high test form fasted	Experimental	Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state Receives: Drug: LY2409021 Test-High Formulation (high particle size)

What is being measured

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

Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form
AUC from time 0 to infinity (AUC0-∞).
Measured: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form
Measured: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

Secondary outcomes (5)

Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting
AUC from time 0 to infinity (AUC0-∞).
Measured: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting
Measured: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Time to Maximum Concentration (Tmax)
Measured: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size
AUC from time 0 to infinity (AUC0-∞).
Measured: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size
Measured: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

Timeline

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

Apr 2011Oct 2011

First posted17 May 2011 (estimated)
Study startApr 2011
Primary completionOct 2011
Study completionOct 2011

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 Healthy VolunteersStudies 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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01354496
Sponsor's protocol ID: 14194
Other IDs: I1R-FW-GLBQ
Status last verified: Nov 2018
First submitted: 13 May 2011
Last updated: 11 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LY2409021 Formulation Bridging and Food Effect Study
ClinicalTrials.gov ID: NCT01354496
Acronym / sponsor ID: 14194
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers, Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 17 May 2011 (estimated)
Results: Posted 11 Mar 2019

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cohort 1 - LY2409021 reference form	Experimental	Drug: LY2409021 Reference FormA 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state
Cohort 1 - LY2409021 medium test form fed	Experimental	Drug: LY2409021 Test-Med Formulation (medium particle size)Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal
Cohort 1 - LY2409021 medium test form fasted	Experimental	Drug: LY2409021 Test-Med Formulation (medium particle size)Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
Cohort 2 - LY2409021 low test form fasted	Experimental	Drug: LY2409021 Test-Low Formulation (low particle size)Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state
Cohort 2 - LY2409021 medium test form fasted	Experimental	Drug: LY2409021 Test-Med Formulation (medium particle size)Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
Cohort 2 - LY2409021 high test form fasted	Experimental	Drug: LY2409021 Test-High Formulation (high particle size)Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state

Who may qualify

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

Key inclusion criteria (5 listed)

Must be healthy male or a healthy female who cannot become pregnant
Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
The veins must be suitable for easy blood collection
Must be willing to be available for the whole study and be willing to follow study procedures

Key exclusion criteria (14 listed)

Were in another new drug or medical research study in the last 30 days
Have previously taken part in this study or any other study with LY2409021
Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
Electrocardiogram (ECG) readings are not suitable for 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
LY2409021 Reference FormAdministered orally	Drug	Cohort 1 - LY2409021 reference form
LY2409021 Test-Med Formulation (medium particle size)Administered orally	Drug	Cohort 1 - LY2409021 medium test form fasted, Cohort 1 - LY2409021 medium test form fed, Cohort 2 - LY2409021 medium test form fasted
LY2409021 Test-High Formulation (high particle size)Administered orally	Drug	Cohort 2 - LY2409021 high test form fasted
LY2409021 Test-Low Formulation (low particle size)Administered orally	Drug	Cohort 2 - LY2409021 low test form fasted

Primary outcome

Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form
Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
AUC from time 0 to infinity (AUC0-∞).
Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form
Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

5 secondary outcomes

Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting
Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting
Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Time to Maximum Concentration (Tmax)
Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size
Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size
Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

Results and safety

Results posted to the registry on 11 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2409021 Cohort 1: Sequence 1	6	6
LY2409021 Cohort 1: Sequence 2	6	6
LY2409021 Cohort 1: Sequence 3	6	4
LY2409021 Cohort 2: Sequence 4	6	6
LY2409021 Cohort 2: Sequence 5	5	5
LY2409021 Cohort 2: Sequence 6	6	6

Primary outcome: Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form

Time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose). Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hour per milliliter (ng*hr/mL)

Measure	LY2409021 Cohort 1 (Test-Medium Tablet Fasted) n = 16	LY2409021 Cohort 1 (Reference Capsules Fasted) n = 15
Value	65300 (20)	62800 (38)

LY2409021 Cohort 1 (Test-Medium Tablet Fasted) vs LY2409021 Cohort 1 (Reference Capsules Fasted): Ratio of geometric least squares means: 1.03 (90% CI 0.897 to 1.18)

Population analysed: Randomized participants in Cohort 1 who received the specified study drug.

Primary outcome: Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form

Measure	LY2409021 Cohort 1 (Test-Medium Tablet Fasted) n = 16	LY2409021 Cohort 1 (Reference Capsules Fasted) n = 15
Value	779 (19)	726 (41)

LY2409021 Cohort 1 (Test-Medium Tablet Fasted) vs LY2409021 Cohort 1 (Reference Capsules Fasted): Ratio of geometric least squares means: 1.06 (90% CI 0.922 to 1.22)

Population analysed: Randomized participants in Cohort 1 who received the specified study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2409021 Cohort 1 (Reference Capsules Fasted)	0 of 15 (0%)	12 of 15 (80%)	Not reported
LY2409021 Cohort 1 (Test-Medium Tablet Fed)	0 of 18 (0%)	17 of 18 (94.4%)	Not reported
LY2409021 Cohort 2 (Test-Low Tablet Fasted)	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
LY2409021 Cohorts 1 and 2 (Test-Medium Tablet Fasted)	0 of 33 (0%)	22 of 33 (66.7%)	Not reported
LY2409021 Cohort 2 (Test-High Tablet Fasted)	0 of 17 (0%)	9 of 17 (52.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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?

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 5 inclusion and 14 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 11 Mar 2019. 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 11 Mar 2019). 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, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form (time frame: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 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 NCT01354496.

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 11 Mar 2019.