Healthy VolunteersPhase 1NCT02156492

A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants

A Phase 1 study testing Evacetrapib, Simvastatin and Atorvastatin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in China.

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 main purpose of this study is to investigate how the body responds to evacetrapib and to evaluate the safety and the effect of evacetrapib, alone and in combination with selected statins, in healthy Chinese participants. The study has 2 parts. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Evacetrapib, Simvastatin and Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteChina
Study dates: Jun 2014to Dec 2014
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 native Chinese and living in China.
Are overtly healthy males or females as determined by medical history and physical examination.
Female participants:
Women not of child-bearing potential
Women of child-bearing potential must correctly use 2 forms of reliable contraception to avoid getting pregnant during the study and for 3 months after the study is completed.
Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m^2)

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BP and pulse rate at both supine and standing positions of approximately a systolic BP ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg
Participants with untreated hypercholesterolemia may be included if not on an herbal or other traditional Chinese medicines (TCM)
Have no known liver disease
Have given written informed consent

Who cannot join

Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device, 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 evacetrapib, simvastatin, or atorvastatin, related compounds or any components of the formulation
Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.
Have a history within the last year or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic 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 evidence of significant active neuropsychiatric disease.
Regularly use known drugs of abuse

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Are women with a positive pregnancy test or women who are lactating.
Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements) or TCM 14 days prior to the first dose and during the study.
Hormonal contraceptives are permitted.
Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1), or of any other transporters involved in simvastatin or atorvastatin disposition, or of any drugs or substances that are known to be strong inducers or inhibitors of cytochrome P450 3A (CYP3A) within 30 days prior to the first dose and throughout the study.
Donated blood of >400 mL within the last month.
Drink alcoholic beverages with intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing until discharge from the clinical research unit (CRU) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
Are unwilling to comply with the dietary requirements/restrictions during the study

Trial locations and contacts

1 site in 1 country.

China1 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.
Beijing, 100034

Other trials in China

About this study

Official title: A Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Study of Evacetrapib With Selected Statins in Healthy Chinese Subjects

Conditions: Healthy Volunteers
Being tested: Evacetrapib, Simvastatin, Atorvastatin

What participants receive

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

EvacetrapibDrug
Also called LY2484595
Administered orally.
SimvastatinDrug
Administered orally.
AtorvastatinDrug
Administered orally.

Study groups in NCT02156492
Study group	Role	What they receive
Evacetrapib Single	Experimental	Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib. Receives: Drug: Evacetrapib
Evacetrapib Multiple	Experimental	Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib for 14 days. Receives: Drug: Evacetrapib
Simvastatin	Active comparator	Part 2, Cohorts B, Participants will receive simvastatin orally, once daily on Days 1 - 4. Receives: Drug: Simvastatin
Evacetrapib and Simvastatin	Experimental	Part 2, Cohorts B, Participants will receive evacetrapib orally once daily on Days 5 - 14 and simvastatin orally, once daily on Days 15 - 22. Receives: Drug: Evacetrapib; Drug: Simvastatin
Atorvastatin	Active comparator	Part 2, Cohorts C, Participants will receive atorvastatin orally, once daily on Days 1 - 4. Receives: Drug: Atorvastatin
Evacetrapib and Atorvastatin	Experimental	Part 2, Cohorts C, Participants will receive evacetrapib orally once daily on Days 5 - 14 and atorvastatin orally, once daily on Days 15 - 22. Receives: Drug: Evacetrapib; Drug: Atorvastatin

What is being measured

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

Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib
Pharmacokinetic (PK) parameter estimates from evacetrapib concentrations following single dose and daily dose of 130 mg evacetrapib.
Measured: Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose
PK: Maximum Concentration (Cmax) of Evacetrapib
Pharmacokinetic parameter estimates from evacetrapib following single dose and daily doses of 130 mg.
Measured: Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose
PK: Time to Maximum Concentration (Tmax) of Evacetrapib
Pharmacokinetic parameter estimates of evacetrapib following single and daily doses of 130 mg evacetrapib.
Measured: Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.
PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin
Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily AUC (0-24).
Measured: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose
PK: Cmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily.
Measured: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.
PK: Tmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
Pharmacokinetic parameter estimates of Tmax of evacetrapib following 130 mg daily dose alone or with 40 mg Simvastatin or 20 mg Atorvastatin. Tmax of simvastatin and atorvastatin.
Measured: Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.

Secondary outcomes (1)

Effect of Evacetrapib Single and Multiple Doses on High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
Measured: Single Dose Day 2 and Multiple Dose Day 22

Timeline

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

Jun 2014Dec 2014

First posted5 Jun 2014 (estimated)
Study startJun 2014
Primary completionDec 2014
Study completionDec 2014

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: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02156492
Sponsor's protocol ID: 14467
Other IDs: I1V-MC-EIAM
Status last verified: Feb 2018
First submitted: 28 May 2014
Last updated: 10 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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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Study of Evacetrapib With Selected Statins in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT02156492
Acronym / sponsor ID: 14467
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 5 Jun 2014 (estimated)
Results: Posted 10 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: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Evacetrapib Single	Experimental	Drug: EvacetrapibPart 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.
Evacetrapib Multiple	Experimental	Drug: EvacetrapibPart 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib for 14 days.
Simvastatin	Active comparator	Drug: SimvastatinPart 2, Cohorts B, Participants will receive simvastatin orally, once daily on Days 1 - 4.
Evacetrapib and Simvastatin	Experimental	Drug: Evacetrapib, Drug: SimvastatinPart 2, Cohorts B, Participants will receive evacetrapib orally once daily on Days 5 - 14 and simvastatin orally, once daily on Days 15 - 22.
Atorvastatin	Active comparator	Drug: AtorvastatinPart 2, Cohorts C, Participants will receive atorvastatin orally, once daily on Days 1 - 4.
Evacetrapib and Atorvastatin	Experimental	Drug: Evacetrapib, Drug: AtorvastatinPart 2, Cohorts C, Participants will receive evacetrapib orally once daily on Days 5 - 14 and atorvastatin orally, once daily on Days 15 - 22.

Who may qualify

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

Key inclusion criteria (10 listed)

Are native Chinese and living in China.
Are overtly healthy males or females as determined by medical history and physical examination.
Female participants:
Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m^2)
BP and pulse rate at both supine and standing positions of approximately a systolic BP ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg

Key exclusion criteria (13 listed)

Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device, 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 evacetrapib, simvastatin, or atorvastatin, related compounds or any components of the formulation
Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.
Have a history within the last year or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic 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 evidence of significant active neuropsychiatric disease.

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
EvacetrapibAlso: LY2484595Administered orally.	Drug	Evacetrapib Multiple, Evacetrapib Single, Evacetrapib and Atorvastatin, Evacetrapib and Simvastatin
SimvastatinAdministered orally.	Drug	Evacetrapib and Simvastatin, Simvastatin
AtorvastatinAdministered orally.	Drug	Atorvastatin, Evacetrapib and Atorvastatin

Primary outcome

Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib
Time frame: Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose
Pharmacokinetic (PK) parameter estimates from evacetrapib concentrations following single dose and daily dose of 130 mg evacetrapib.
PK: Maximum Concentration (Cmax) of Evacetrapib
Time frame: Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose
Pharmacokinetic parameter estimates from evacetrapib following single dose and daily doses of 130 mg.
PK: Time to Maximum Concentration (Tmax) of Evacetrapib
Time frame: Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.
Pharmacokinetic parameter estimates of evacetrapib following single and daily doses of 130 mg evacetrapib.
PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin
Time frame: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose
Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily AUC (0-24).
PK: Cmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
Time frame: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.
Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily.
PK: Tmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
Time frame: Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.
Pharmacokinetic parameter estimates of Tmax of evacetrapib following 130 mg daily dose alone or with 40 mg Simvastatin or 20 mg Atorvastatin. Tmax of simvastatin and atorvastatin.

1 secondary outcome

Effect of Evacetrapib Single and Multiple Doses on High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
Time frame: Single Dose Day 2 and Multiple Dose Day 22

Results and safety

Results posted to the registry on 10 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
Cohort A: Evacetrapib Single and Multiple Dose	16	16
Cohort B: Evacetrapib and Simvastatin	24	23
Cohort C: Evacetrapib and Atorvastatin	22	22

Primary outcome: Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib

Time frame: Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram * hour per milliliter (ng*h/mL)

Measure	Evacetrapib Single and Multiple Dose n = 16
Day 1	7700 (74)
Day 14	23600 (33)

Population analysed: All participants who received at least one dose of study drug in Cohort A.

Primary outcome: PK: Maximum Concentration (Cmax) of Evacetrapib

Time frame: Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Evacetrapib Single and Multiple Dose n = 16
Single Dose Day 1	418 (118)
Multiple Dose Day 14	954 (52)

Population analysed: All participants who received at least one dose of study drug in Cohort A.

Primary outcome: PK: Time to Maximum Concentration (Tmax) of Evacetrapib

Time frame: Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.. Median (Full Range). Unit: hours (h)

Measure	Evacetrapib Single and Multiple Dose n = 16
Single Dose Day 1	3.00 (2.00 to 6.00)
Daily Dose Day 14	3.00 (2.00 to 4.00)

Population analysed: All participants who received at least one dose of study drug in Cohort A.

Primary outcome: PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin

Time frame: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Evacetrapib Daily and Simvastatin n = 23	Evacetrapib Daily and Atorvastatin n = 22
Days 5-14	10700 (36)	10600 (30)
Days 15-22	9640 (48)	9480 (53)

Population analysed: All participants who received at least one dose of study drug in Cohort B and C and had evaluable PK data

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evacetrapib Single Cohort A	0 of 16 (0%)	0 of 16 (0%)	Not reported
Evacetrapib Multiple	0 of 16 (0%)	0 of 16 (0%)	Not reported
Simvastatin	0 of 24 (0%)	0 of 24 (0%)	Not reported
Evacetrapib Single Cohort B	0 of 23 (0%)	0 of 23 (0%)	Not reported
Evacetrapib and Simvastatin	0 of 23 (0%)	0 of 23 (0%)	Not reported
Atorvastatin	0 of 22 (0%)	0 of 22 (0%)	Not reported
Evacetrapib Single Cohort C	0 of 22 (0%)	0 of 22 (0%)	Not reported
Evacetrapib and Atorvastatin	0 of 22 (0%)	0 of 22 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 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 Evacetrapib, Simvastatin and Atorvastatin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in China.

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 13 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 10 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 China. 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 10 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 (PK): Area Under Curve (AUC 0-inf) of Evacetrapib (time frame: Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose). The study lists 6 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 NCT02156492.

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 10 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.