Healthy VolunteersPhase 1NCT01313286

A Study to Compare Two Forms of LY2608204 in Healthy People

A Phase 1 study testing LY2608204 Reference and LY2608204 Test 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 purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. 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?: LY2608204 Reference and LY2608204 Test
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSingapore
Study dates: Mar 2011to Apr 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 a healthy male or a female who cannot become pregnant
Must have body mass index (BMI) of 18.5 to 32 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
Must have given written informed consent

Who cannot join

Were in another new drug or medical research study in the last 30 days
Have participated in this study or any other study with LY2608204 before
Have taken drugs similar to LY2608204 (glucokinase activators) before and was found to be allergic to the drug
Have drug allergy to more than 3 types of medications given by injection
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

Show all 15Show fewer

Are infected with hepatitis B
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
Are unwilling to follow dietary restrictions/requirements for the study including (i) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay; (ii) consume only the meals provided during dosing day at the clinical research unit (CRU)
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 milliliter (mL) or more of blood in the last 3 months (this is about the same as the usual volume given in a blood donation)
The study doctor thinks the subject 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 personal physician.
Singapore

Other trials in Singapore

About this study

Official title: The Relative Bioavailability of a Proposed Phase 2 LY2608204 Test Formulation Compared With the Current Phase 1 LY2608204 Reference Formulation After Administration of a Single Oral 80-mg Dose in Healthy Subjects

Conditions: Healthy Volunteers
Being tested: LY2608204 Reference, LY2608204 Test
Keywords: Diabetes Mellitus, Type 2
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

LY2608204 ReferenceDrug
Also called Glucokinase Activator
Administered orally
LY2608204 TestDrug
Also called Glucokinase Activator
Administered orally.

Study groups in NCT01313286
Study group	Role	What they receive
LY2608204 Reference, LY2608204 Test	Experimental	Single oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods. Receives: Drug: LY2608204 Reference; Drug: LY2608204 Test
LY2608204 Test, LY2608204 Reference	Experimental	Single oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY2608204 reference formulation in period 2. There is a washout period of at least 14 days between dosing periods. Receives: Drug: LY2608204 Reference; Drug: LY2608204 Test

What is being measured

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

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
Area under the concentration versus time curve from zero to infinity [AUC(0-∞)] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Measured: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
Maximum Observed Drug Concentration (Cmax)
Maximum observed drug concentration (Cmax) was observed from the data. The values for Cmax were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Measured: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours

Timeline

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

Mar 2011Apr 2011

First posted11 Mar 2011 (estimated)
Study startMar 2011
Primary completionApr 2011
Study completionApr 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: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01313286
Sponsor's protocol ID: 14233
Other IDs: I3P-FW-GKBG
Status last verified: Oct 2018
First submitted: 10 Mar 2011
Last updated: 5 Oct 2018
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 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relative Bioavailability of a Proposed Phase 2 LY2608204 Test Formulation Compared With the Current Phase 1 LY2608204 Reference Formulation After Administration of a Single Oral 80-mg Dose in Healthy Subjects
ClinicalTrials.gov ID: NCT01313286
Acronym / sponsor ID: 14233
Conditions: Healthy Volunteers
Keywords: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 11 Mar 2011 (estimated)
Results: Posted 5 Oct 2018

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: 2

Arm	Type	Receives
LY2608204 Reference, LY2608204 Test	Experimental	Drug: LY2608204 Reference, Drug: LY2608204 TestSingle oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods.
LY2608204 Test, LY2608204 Reference	Experimental	Drug: LY2608204 Reference, Drug: LY2608204 TestSingle oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY2608204 reference formulation in period 2. There is a washout period of at least 14 days between dosing periods.

Who may qualify

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

Key inclusion criteria (6 listed)

Must be a healthy male or a female who cannot become pregnant
Must have body mass index (BMI) of 18.5 to 32 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 (15 listed)

Were in another new drug or medical research study in the last 30 days
Have participated in this study or any other study with LY2608204 before
Have taken drugs similar to LY2608204 (glucokinase activators) before and was found to be allergic to the drug
Have drug allergy to more than 3 types of medications given by injection
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

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
LY2608204 ReferenceAlso: Glucokinase ActivatorAdministered orally	Drug	LY2608204 Reference, LY2608204 Test, LY2608204 Test, LY2608204 Reference
LY2608204 TestAlso: Glucokinase ActivatorAdministered orally.	Drug	LY2608204 Reference, LY2608204 Test, LY2608204 Test, LY2608204 Reference

Primary outcome

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
Time frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
Area under the concentration versus time curve from zero to infinity [AUC(0-∞)] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Maximum Observed Drug Concentration (Cmax)
Time frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
Maximum observed drug concentration (Cmax) was observed from the data. The values for Cmax were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.

Results and safety

Results posted to the registry on 5 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2608204 Reference, LY2608204 Test	8	6
LY2608204 Test, LY2608204 Reference	8	8

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

Time frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram.hour per milliliter (ng.h/mL)

Measure	LY2608204 Free Base (Reference Formulation) n = 16	LY2608204 Hydrochloride (HCl) Salt (Test Formulation) n = 14
Value	974 (39)	1080 (35)

LY2608204 Free Base (Reference Formulation) vs LY2608204 Hydrochloride (HCl) Salt (Test Formulation): Ratio of Geometric Least Square means: 1.08 (90% CI 1.00 to 1.16), Mixed Models Analysis

Population analysed: All randomized participants who took at least one dose of study drug.

Primary outcome: Maximum Observed Drug Concentration (Cmax)

Time frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	LY2608204 Free Base (Reference Formulation) n = 16	LY2608204 Hydrochloride (HCl) Salt (Test Formulation) n = 14
Value	24.9 (27)	30.3 (33)

LY2608204 Free Base (Reference Formulation) vs LY2608204 Hydrochloride (HCl) Salt (Test Formulation): Ratio of Geometric Least Square means: 1.18 (90% CI 1.07 to 1.31), Mixed Models Analysis

Population analysed: All randomized participants who took at least one dose of study drug.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2608204 Reference Formulation	0 of 16 (0%)	10 of 16 (62.5%)	Not reported
LY2608204 Test Formulation	0 of 14 (0%)	10 of 14 (71.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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 9AM - 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 LY2608204 Reference and LY2608204 Test in people with Healthy Volunteers, 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 6 inclusion and 15 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 5 Oct 2018. 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 5 Oct 2018). 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?

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) (time frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours). 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 NCT01313286.

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 5 Oct 2018.