Healthy Volunteer StudyPhase 1NCT01609218

A Study of LY2140023 in Healthy Participants

A Phase 1 study testing LY2140023 and Aqueous activated charcoal in people with Healthy Volunteer Study, run by Denovo Biopharma LLC at 1 site in United Kingdom.

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 study will evaluate the effect of activated charcoal on absorption of LY2140023. The study involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth 2 times during study (once with activated charcoal, once without activated charcoal). Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer Study
What is being tested?: LY2140023 and Aqueous activated charcoal
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited Kingdom
Study dates: Jun 2012to Sep 2012
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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

are healthy males or females, as determined by medical history and physical examination
male participants agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023, and agree not to donate sperm for 3 months following the last dose of LY2140023
female participants:
of childbearing potential, who test negative for pregnancy at screening and who agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023
of non-childbearing potential; postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or confirmed tubal occlusion (not tubal ligation). Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a plasma follicle-stimulating hormone (FSH) level >40 milli-international units per milliliter(mIU/mL), unless the participant is taking hormone replacement therapy
have given written informed consent approved by Lilly and the chosen ethical review board (ERB)

Who cannot join

are currently enrolled in, have completed or discontinued within the last 90 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
have known allergies to LY2140023 or LY404039, related compounds, activated charcoal, or any components of the formulation
are participants who have previously withdrawn from this study or any other study investigating LY2140023 after receiving at least 1 dose of LY2140023
show evidence or any history of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
have increased risk of seizures based on a history of:
one or more seizures (except for a single simple febrile seizure [lacking focality and lasting less than 15 minutes, not associated with a central nervous system (CNS) infection or severe metabolic disturbance] as a child between ages 6 months to 5 years)

Show all 16Show fewer

head trauma with loss of consciousness or a post-concussive syndrome within 1 year or lifetime history of head trauma with persistent neurological deficit (focal or diffuse)
CNS infection, uncontrolled migraine, or transient ischemic attack (TIA) within 1 year; stroke with persistent neurological deficit (focal or diffuse). Uncontrolled migraine is defined as migraine attacks that produce headache lasting up to 72 hours and are often accompanied by associated symptoms (nausea, photophobia, and phonophobia) that impair well-being and disrupt social functioning. TIA is defined as "mini-stroke" caused by temporary disturbance of blood supply to an area of the brain, which results in a sudden, brief decrease in brain function
CNS infection with persistent neurological deficit (focal or diffuse)
brain surgery
electroencephalogram (EEG) with paroxysmal (epileptiform) activity (isolated spikes waves, repetitive bursts of sharp waves, paroxysmal activity, frank seizures, spike-wave complexes, or sharp-slow wave complexes, or as locally defined)
brain structural lesion, including developmental abnormalities, as determined by examination or imaging studies (except hydrocephalus treated by shunt and without neurological deficit)
show evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance less than 90 milliliters per minute (mL/min) as determined by the Cockroft Gault formula
show evidence or any history of known substance dependence or abuse at any time (according to Diagnostic and Statistical Manual of Mental Disorders [DSM-IV] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
have a clinically significant abnormality in the neurological examination
participants judged prior to randomization to be at suicidal risk by the investigator

Trial locations and contacts

1 site in 1 country.

United Kingdom1 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.
Leeds, West Yorkshire, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A Study to Evaluate the Impact of Activated Charcoal on the Absorption of LY2140023 in Healthy Subjects

Conditions: Healthy Volunteer Study
Being tested: LY2140023, Aqueous activated charcoal

What participants receive

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

LY2140023Drug
Aqueous activated charcoalDrug

Study groups in NCT01609218
Study group	Role	What they receive
80 mg LY2140023	Experimental	Single oral dose of 80 milligrams (mg) LY2140023 administered alone Receives: Drug: LY2140023
80 mg LY2140023 + 75 g aqueous activated charcoal	Experimental	Single oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 grams (g) aqueous activated charcoal. Receives: Drug: LY2140023; Drug: Aqueous activated charcoal

What is being measured

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

Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2140023
Venous blood samples were collected for pharmacokinetic parameter estimates for LY2140023 alone and in the presence of aqueous activated charcoal.
Measured: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2140023
Venous blood samples were collected for pharmacokinetic parameter estimates for LY2140023 alone and in the presence of aqueous activated charcoal.
Measured: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY404039 (Active Moiety)
Venous blood samples were collected for pharmacokinetic parameter estimates for LY404039 alone and in the presence of aqueous activated charcoal.
Measured: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY404039 (Active Moiety)
Venous blood samples were collected for pharmacokinetic parameter estimates for LY404039 alone and in the presence of aqueous activated charcoal.
Measured: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

Timeline

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

Jun 2012Sep 2012

First posted31 May 2012 (estimated)
Study startJun 2012
Primary completionSep 2012
Study completionSep 2012

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 Volunteer StudyStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01609218
Sponsor's protocol ID: 12858
Other IDs: H8Y-MC-HBCZ
Status last verified: Oct 2012
First submitted: 29 May 2012
Last updated: 21 Sep 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 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Impact of Activated Charcoal on the Absorption of LY2140023 in Healthy Subjects
ClinicalTrials.gov ID: NCT01609218
Acronym / sponsor ID: 12858
Conditions: Healthy Volunteer Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Denovo Biopharma LLCIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 31 May 2012 (estimated)
Results: Posted 21 Sep 2021

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
80 mg LY2140023	Experimental	Drug: LY2140023Single oral dose of 80 milligrams (mg) LY2140023 administered alone
80 mg LY2140023 + 75 g aqueous activated charcoal	Experimental	Drug: LY2140023, Drug: Aqueous activated charcoalSingle oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 grams (g) aqueous activated charcoal.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

are healthy males or females, as determined by medical history and physical examination
male participants agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023, and agree not to donate sperm for 3 months following the last dose of LY2140023
female participants:
have given written informed consent approved by Lilly and the chosen ethical review board (ERB)

Key exclusion criteria (16 listed)

are currently enrolled in, have completed or discontinued within the last 90 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
have known allergies to LY2140023 or LY404039, related compounds, activated charcoal, or any components of the formulation
are participants who have previously withdrawn from this study or any other study investigating LY2140023 after receiving at least 1 dose of LY2140023
show evidence or any history of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
have increased risk of seizures based on a history of:

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
LY2140023	Drug	80 mg LY2140023, 80 mg LY2140023 + 75 g aqueous activated charcoal
Aqueous activated charcoal	Drug	80 mg LY2140023 + 75 g aqueous activated charcoal

Primary outcome

Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2140023
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY2140023 alone and in the presence of aqueous activated charcoal.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2140023
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY2140023 alone and in the presence of aqueous activated charcoal.
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY404039 (Active Moiety)
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY404039 alone and in the presence of aqueous activated charcoal.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY404039 (Active Moiety)
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Venous blood samples were collected for pharmacokinetic parameter estimates for LY404039 alone and in the presence of aqueous activated charcoal.

Results and safety

Results posted to the registry on 21 Sep 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
First LY2140023 Alone, Then LY2140023 + Activated Charcoal	13	10
First LY2140023 + Activated Charcoal, Then LY2140023 Alone	14	8

Primary outcome: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2140023

Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	80 mg LY2140023 n = 18	80 mg LY2140023 + 75 g Aqueous Activated Charcoal n = 14
Value	251 (31)	171 (25)

Population analysed: Participants who received study drug(s), did not have an incidence of vomiting following administration of LY2140023, and had evaluable Cmax data.

Primary outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2140023

Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram hours per milliliter (ng*h/mL)

Measure	80 mg LY2140023 n = 18	80 mg LY2140023 + 75 g Aqueous Activated Charcoal n = 14
Value	1120 (24)	876 (26)

Population analysed: Participants who received study drug(s), did not have an incidence of vomiting following administration of LY2140023, and had evaluable AUC(0-inf) data.

Primary outcome: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY404039 (Active Moiety)

Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	80 mg LY2140023 n = 18	80 mg LY2140023 + 75 g Aqueous Activated Charcoal n = 14
Value	474 (26)	324 (20)

Population analysed: Participants who received study drug(s), did not have an incidence of vomiting following administration of LY2140023, and had evaluable Cmax data.

Primary outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY404039 (Active Moiety)

Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	80 mg LY2140023 n = 18	80 mg LY2140023 + 75 g Aqueous Activated Charcoal n = 14
Value	2780 (15)	2190 (19)

Population analysed: Participants who received study drug(s), did not have an incidence of vomiting following administration of LY2140023, and had evaluable AUC(0-inf) data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
80 mg LY2140023	0 of 22 (0%)	16 of 22 (72.7%)	Not reported
80 mg LY2140023 + 75 g Aqueous Activated Charcoal	0 of 24 (0%)	13 of 24 (54.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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 LY2140023 and Aqueous activated charcoal in people with Healthy Volunteer Study, run by Denovo Biopharma LLC at 1 site in United Kingdom.

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 16 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 21 Sep 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 United Kingdom. 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 21 Sep 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: Maximum Observed Plasma Concentration (Cmax) of LY2140023 (time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose). The study lists 4 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 NCT01609218.

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 21 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.