InsomniaPhase 1NCT01236105

Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy Subject

A Phase 1 study testing LY2624803 and Activated Charcoal in people with Insomnia, run by Eli Lilly and Company 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 purpose of this study is to determine the effect of activated charcoal and dosing time on the absorption of LY2624803 in healthy subjects. In this crossover study, there are three treatments with a washout period of at least 7 days in between treatments. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: LY2624803 and Activated Charcoal
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2010to Dec 2010
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 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.
Male subjects with female partners of child-bearing potential and female subjects of child-bearing potential, agree to use 2 reliable methods of contraception from the time of the first dose until 3 months after the last dose of study drug or are women not of child-bearing potential due to postmenopausal or permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral salpingectomy]).
Have a body mass index (BMI) between 18.5 and 32 kilograms per square meter (kg/m2), inclusive, and a body weight of 50 kg or above at screening.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have venous access sufficient to allow blood sampling as per the protocol.
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Have given written informed consent approved by Lilly and the ethical review board governing the site.

Who cannot join

Are currently enrolled in, or discontinued within the last 90 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug 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 LY2624803 or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2624803.
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
Have an abnormal blood pressure as determined by the investigator.
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (except appendectomy), endocrine, hematological, dermatological, venereal, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data.

Show all 19Show fewer

Show evidence or history of postural hypotension, loss of consciousness, explained or unexplained syncope or seizure episodes or a family history of seizures. A history of a single febrile convulsion is acceptable.
Show evidence of significant active neuropsychiatric disease.
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
Are women with a positive pregnancy test or women who are lactating.
Intend to use over-the-counter or prescription medications, with the exception of vitamins and paracetamol, which cannot be safely discontinued within 7 days prior to admission.
Have donated blood of more than 500 milliliters (mL) within the last 3 months prior to screening.
Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), and are subjects unwilling to stop alcohol consumption from 48 hours prior to admission until discharge from the unit for each treatment period, and to limit alcohol intake to a maximum of 2 units/day between treatment periods.
Have a history of breast cancer.
Are subjects with excessive xanthine consumption.
Exhibit any other condition, which, in the opinion of the investigator would preclude participation in the study.

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: Evaluation of the Impact of Activated Charcoal and Time of Dose on the Absorption of LY2624803 in Healthy Subjects

Conditions: Insomnia
Being tested: LY2624803, Activated Charcoal
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

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

LY2624803Drug
Administered orally (po), once.
Activated CharcoalOther
Administered po

Study groups in NCT01236105
Study group	Role	What they receive
6 mg LY2624803 Alone Morning Dosing	Experimental	Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast. Receives: Drug: LY2624803
6 mg LY2624803 Morning Dosing + Activated Charcoal	Experimental	Participants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola. Receives: Drug: LY2624803; Other: Activated Charcoal
6 mg LY2624803 Alone Evening Dosing	Experimental	Participants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast. Receives: Drug: LY2624803

What is being measured

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

Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276
AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.
Measured: Predose and up to Day 4
Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,
Cmax estimated for both LY2624803 and the metabolite LSN2797276.
Measured: Predose and up to Day 4

Secondary outcomes (1)

Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276
Tmax, estimated for both LY2624803 and the metabolite LSN2797276.
Measured: Predose and up to day 4

Timeline

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

Oct 2010Dec 2010

First posted8 Nov 2010 (estimated)
Study startOct 2010
Primary completionDec 2010
Study completionDec 2010

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 InsomniaStudies 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: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01236105
Sponsor's protocol ID: 12814
Other IDs: I2K-MC-ZZBQ
Status last verified: Nov 2011
First submitted: 4 Nov 2010
Last updated: 22 Dec 2011
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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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Impact of Activated Charcoal and Time of Dose on the Absorption of LY2624803 in Healthy Subjects
ClinicalTrials.gov ID: NCT01236105
Acronym / sponsor ID: 12814
Conditions: Insomnia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 8 Nov 2010 (estimated)
Results: Posted 22 Dec 2011

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: 3

Arm	Type	Receives
6 mg LY2624803 Alone Morning Dosing	Experimental	Drug: LY2624803Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast.
6 mg LY2624803 Morning Dosing + Activated Charcoal	Experimental	Drug: LY2624803, Other: Activated CharcoalParticipants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
6 mg LY2624803 Alone Evening Dosing	Experimental	Drug: LY2624803Participants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Are overtly healthy males or females, as determined by medical history and physical examination.
Male subjects with female partners of child-bearing potential and female subjects of child-bearing potential, agree to use 2 reliable methods of contraception from the time of the first dose until 3 months after the last dose of study drug or are women not of child-bearing potential due to postmenopausal or permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral salpingectomy]).
Have a body mass index (BMI) between 18.5 and 32 kilograms per square meter (kg/m2), inclusive, and a body weight of 50 kg or above at screening.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have venous access sufficient to allow blood sampling as per the protocol.

Key exclusion criteria (19 listed)

Are currently enrolled in, or discontinued within the last 90 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug 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 LY2624803 or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2624803.
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
Have an abnormal blood pressure as determined by the investigator.

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
LY2624803Administered orally (po), once.	Drug	6 mg LY2624803 Alone Evening Dosing, 6 mg LY2624803 Alone Morning Dosing, 6 mg LY2624803 Morning Dosing + Activated Charcoal
Activated CharcoalAdministered po	Other	6 mg LY2624803 Morning Dosing + Activated Charcoal

Primary outcome

Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276
Time frame: Predose and up to Day 4
AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.
Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,
Time frame: Predose and up to Day 4
Cmax estimated for both LY2624803 and the metabolite LSN2797276.

1 secondary outcome

Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276
Time frame: Predose and up to day 4

Results and safety

Results posted to the registry on 22 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2624803	21	21

Primary outcome: Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276

Time frame: Predose and up to Day 4. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	LY2624803 Alone Morning Dosing n = 21	LY2624803 Morning Dosing Plus Activated Charcoal n = 20	LY2624803 Alone Evening Dosing n = 21
LY2624803	5240 (30)	3340 (30)	4620 (30)
LSN2797276 (N=18, 12, 15)	192 (23)	112 (19)	188 (26)

Population analysed: All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.

Primary outcome: Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,

Time frame: Predose and up to Day 4. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	LY2624803 Alone Morning Dosing n = 21	LY2624803 Morning Dosing Plus Activated Charcoal n = 20	LY2624803 Alone Evening Dosing n = 21
LY2624803	368 (26)	335 (35)	273 (17)
LSN2797276	6.22 (27)	5.11 (41)	5.94 (28)

Population analysed: All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2624803 Morning Dosing	0 of 21 (0%)	13 of 21 (61.9%)	Not reported
LY2624803 Morning Dosing + Activated Charcoal	0 of 21 (0%)	8 of 21 (38.1%)	Not reported
LY2624803 Evening Dosing	0 of 21 (0%)	10 of 21 (47.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
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Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Recruiting
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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 LY2624803 and Activated Charcoal in people with Insomnia, run by Eli Lilly and Company 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 7 inclusion and 19 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 22 Dec 2011. 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 22 Dec 2011). 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-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276 (time frame: Predose and up to Day 4). 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 NCT01236105.

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 22 Dec 2011.