Major Depressive DisorderPhase 1NCT01263093

A Pharmacokinetic Study on the Effect of LY2216684 on the Active Metabolite of Clopidogrel

A Phase 1 study testing Clopidogrel and LY2216684 in people with Major Depressive Disorder, run by Eli Lilly and Company at 1 site in United States.

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 purpose of this study is to measure how much of the study drugs (clopidogrel and LY2216684) reach the blood stream and how long it takes the body to dispose of them and to determine how clopidogrel and LY2216684 might affect each other in the body. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: Clopidogrel and LY2216684
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Mar 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are overtly healthy, as determined by medical history and physical examination.
Male participants - Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Female participants - Women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 milli-international units per milliliter [mIU/mL]).
Have a body weight >50 kilograms (kg).
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.

Show all 10Show fewer

Have normal blood pressure and pulse rate (sitting position) as determined by the investigator.
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 (ERB) governing the site.
Are cytochrome P450 (CYP) 2C19 extensive metabolizers or ultra -rapid metabolizers as determined by genotyping assessment.

Who cannot join

Are currently enrolled in, or discontinued within the last 30 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, 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 LY2216684, clopidogrel, or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to screening.
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 a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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.
Have a history of or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation.

Show all 30Show fewer

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 medication within 14 days prior to dosing unless deemed acceptable by the investigator and Sponsor's medical monitor, except for influenza vaccinations.
Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP2C19 or CYP3A4 within 30 days prior to dosing.
Have donated blood of more than 500 milliliters (mL) within the last month.
Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to check-in until completion of the study (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any participants unwilling to adhere to study caffeine restrictions.
Have used any tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to enrollment.
Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment and during the study.
Have a documented or suspected history of glaucoma.
History or presence of significant bleeding disorders that is, haematemesis, melanena, severe or recurrent epistaxis, haemoptysis, clinically overt clinical haematuria or intracranial haemorrhage.
Participants with a history of gastrointestinal ulcers or haemorrhage.
Personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, for example, cerebral haemorrhage, aneurysm or premature stroke (cerebrovascular accident <65 years of age).
Self-reported history of increased bleeding from trauma (for example, prolonged bleeding after tooth extraction).
History of major surgery within 3 months of screening.
Planned surgery within 14 days after the last day of dosing.
International normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT) above the normal reference range or platelet count below the normal reference range at screening.
Positive fecal occult blood examination at screening.
Clinically significant abnormality in fundoscopic or petechiae examination.
Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function within 21 days prior to dosing.
Participants determined to be unsuitable by the investigator for any reason.

Trial locations and contacts

1 site in 1 country.

United States1 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.
Dallas, Texas

Other trials in United States

About this study

Official title: Effect of LY2216684 on the Pharmacokinetics and Pharmacodynamics of R-130964, the Active Metabolite of Clopidogrel, in Healthy Subjects

Read the detailed description

Clopidogrel is rapidly converted to R-130964 by the enzyme cytochrome P450 2C19 (CYP2C19). Enrollment in the study was limited to participants with specific genotypes of the CYP2C19 gene, including the *1/*1 genotype (CYP2C19 extensive metabolizers) and the *1/*17 or *17/*17 genotypes (CYP2C19 ultra-rapid metabolizers). All primary and secondary objectives were limited to participants with the CYP2C19*1/*1 genotype.

Conditions: Major Depressive Disorder
Being tested: Clopidogrel, LY2216684
Medical subject headings: Depressive Disorder, Major

What participants receive

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

ClopidogrelDrug
LY2216684Drug

Study groups in NCT01263093
Study group	Role	What they receive
Clopidogrel First, Then LY2216684 + Clopidogrel	Experimental	Period 1: a single 300-milligram (mg) dose of clopidogrel administered orally on Day 1 (Treatment 1). Period 2: an 18-mg dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2). There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2. Receives: Drug: Clopidogrel; Drug: LY2216684
LY2216684 + Clopidogrel First, Then Clopidogrel	Experimental	Period 1: an 18-milligram (mg) dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2). Period 2: a single 300-mg dose of clopidogrel administered orally on Day 1 (Treatment 1). There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2. Receives: Drug: Clopidogrel; Drug: LY2216684

What is being measured

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

Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684.
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose
Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-tlast)
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed AUC0-tlast was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect.
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose
Pharmacokinetics of R-130964, Maximum Observed Drug Concentrations (Cmax)
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed Cmax was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect.
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose
Pharmacokinetics of R-130964, Time to Maximum Observed Drug Concentrations (Tmax)
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684.
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose

Secondary outcomes (1)

Percentage Inhibition of Platelet Aggregation
Blood samples for the measurement of platelet aggregation using a point-of-care device, Accumetrics VerifyNow™ P2Y12 (VN-P2Y12), were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Device-reported percent inhibition of VN-P2Y12 (IPRU) is presented.
Measured: predose and 2, 4, 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.

Dec 2010Mar 2011

First posted20 Dec 2010 (estimated)
Study startDec 2010
Primary completionMar 2011
Study completionMar 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 Major Depressive DisorderStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01263093
Sponsor's protocol ID: 12593
Other IDs: H9P-EW-LNBY
Status last verified: Mar 2018
First submitted: 16 Dec 2010
Last updated: 22 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?

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of LY2216684 on the Pharmacokinetics and Pharmacodynamics of R-130964, the Active Metabolite of Clopidogrel, in Healthy Subjects
ClinicalTrials.gov ID: NCT01263093
Acronym / sponsor ID: 12593
Conditions: Major Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 20 Dec 2010 (estimated)
Results: Posted 22 Oct 2018

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Clopidogrel First, Then LY2216684 + Clopidogrel	Experimental	Drug: Clopidogrel, Drug: LY2216684Period 1: a single 300-milligram (mg) dose of clopidogrel administered orally on Day 1 (Treatment 1). Period 2: an 18-mg dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2). There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2.
LY2216684 + Clopidogrel First, Then Clopidogrel	Experimental	Drug: Clopidogrel, Drug: LY2216684Period 1: an 18-milligram (mg) dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2). Period 2: a single 300-mg dose of clopidogrel administered orally on Day 1 (Treatment 1). There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2.

Who may qualify

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

Key inclusion criteria (10 listed)

Are overtly healthy, as determined by medical history and physical examination.
Male participants - Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Female participants - Women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 milli-international units per milliliter [mIU/mL]).
Have a body weight >50 kilograms (kg).
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.

Key exclusion criteria (30 listed)

Are currently enrolled in, or discontinued within the last 30 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, 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 LY2216684, clopidogrel, or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to screening.
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 a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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.

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
Clopidogrel	Drug	Clopidogrel First, Then LY2216684 + Clopidogrel, LY2216684 + Clopidogrel First, Then Clopidogrel
LY2216684	Drug	Clopidogrel First, Then LY2216684 + Clopidogrel, LY2216684 + Clopidogrel First, Then Clopidogrel

Primary outcome

Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684.
Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-tlast)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed AUC0-tlast was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect.
Pharmacokinetics of R-130964, Maximum Observed Drug Concentrations (Cmax)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed Cmax was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect.
Pharmacokinetics of R-130964, Time to Maximum Observed Drug Concentrations (Tmax)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose
R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684.

1 secondary outcome

Percentage Inhibition of Platelet Aggregation
Time frame: predose and 2, 4, and 24 hours postdose

Results and safety

Results posted to the registry on 22 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
Clopidogrel First, Then LY2216684 + Clopidogrel	24	24
LY2216684 + Clopidogrel First, Then Clopidogrel	23	23

Primary outcome: Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*nanograms/milliliters (h*ng/mL)

Measure	Clopidogrel n = 31	LY2216684 + Clopidogrel n = 15
Value	61.8 (50)	55.3 (44)

Population analysed: Participants with the CYP2C19\*1/\*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration data, including sufficient data in the terminal elimination phase for R-130964.

Primary outcome: Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-tlast)

Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*nanograms/milliliters (h*ng/mL)

Measure	Clopidogrel n = 38	LY2216684 + Clopidogrel n = 36
Value	60.5 (45)	46.9 (41)

Clopidogrel vs LY2216684 + Clopidogrel: Ratio of Geometric Least Squares Means: 0.77 (90% CI 0.72 to 0.83), Mixed Models Analysis

Population analysed: Participants with the CYP2C19\*1/\*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration data.

Primary outcome: Pharmacokinetics of R-130964, Maximum Observed Drug Concentrations (Cmax)

Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter (ng/mL)

Measure	Clopidogrel n = 38	LY2216684 + Clopidogrel n = 36
Value	37.6 (56)	22.7 (53)

Clopidogrel vs LY2216684 + Clopidogrel: Ratio of Geometric Least Squares Means: 0.59 (90% CI 0.53 to 0.67), Mixed Models Analysis

Population analysed: Participants with the CYP2C19\*1/\*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration data.

Primary outcome: Pharmacokinetics of R-130964, Time to Maximum Observed Drug Concentrations (Tmax)

Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose. Median (Full Range). Unit: hours

Measure	Clopidogrel n = 36	LY2216684 + Clopidogrel n = 36
Value	1.50 (1.00 to 2.07)	1.50 (0.50 to 4.00)

Clopidogrel vs LY2216684 + Clopidogrel: Median of Paired Differences: 0.00 (90% CI 0.00 to 0.25), p = 0.3303, Wilcoxon (Mann-Whitney)

Population analysed: Participants with the CYP2C19\*1/\*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration 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
Clopidogrel	0 of 47 (0%)	12 of 47 (25.5%)	Not reported
LY2216684	0 of 46 (0%)	19 of 46 (41.3%)	Not reported
LY2216684 + Clopidogrel	0 of 45 (0%)	11 of 45 (24.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 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 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 Clopidogrel and LY2216684 in people with Major Depressive Disorder, run by Eli Lilly and Company at 1 site in United States.

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 10 inclusion and 30 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 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 United States. 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 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?

Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) (time frame: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 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 NCT01263093.

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 Oct 2018.