HealthyPhase 1NCT02080468

Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

A Phase 1 study testing lomitapide and EE/norgestimate in people with Healthy, run by Aegerion Pharmaceuticals, Inc. 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

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Trial summary

The primary objective of this study is to assess the effect of ethinyl estradiol (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and 2 primary metabolites, M1 and M3. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: lomitapide and EE/norgestimate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 19 Feb 2014to 24 Apr 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 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy females, between 18 and 40 years of age inclusive
BMI between 18.5 and 30.0 kg/m2, inclusive; total body weight of >110 lbs (50 kg);
in good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history and physical exam
no known history of hypersensitivity or previous intolerance to lomitapide or EE/norgestimate
creatine phosphokinase, AST, and ALT levels must be below 1.5 times the upper limit of normal
clinical laboratory evaluations within the reference range for the test laboratory

Show all 10Show fewer

negative test for selected drugs of abuse
negative hepatitis panel and negative HIV antibody screens
are of childbearing potential(ie, not postmenopausal or surgically sterile). All subjects must have a negative serum beta pregnancy test.
able to comprehend and willing to sign an Informed Consent Form

Who cannot join

significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder
history of unexplained breast abnormalities or abnormal uterine bleeding
history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
history of stomach or intestinal surgery or resection
history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome
subjects who have an abnormality in the 12-lead ECG

Show all 20Show fewer

use of any drugs of abuse for 6 months prior to Check-in;
subjects who consume more than 14 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse within 1 year prior to Check-in
use of any tobacco- or nicotine-containing products within 6 months prior to Check-in;
participation in any other investigational study drug trial within 30 days prior to Check-in;
use of any prescription medications/products within 14 days prior to Check-in unless deemed acceptable by the Investigator and Sponsor
use of any over-the-counter, nonprescription preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator and Sponsor
use of alcohol-, grapefruit- (including star fruit), or caffeine-containing foods or beverages within 72 hours prior to Check-in and through Study Completion
use of oral (except scheduled administration of EE/norgestimate), implantable, injectable, or transdermal contraceptives
use of hormone replacement therapy
poor peripheral venous access;
donation of blood (500 mL) from 30 days prior to Screening through Study Completion
receipt of blood products within 2 months prior to Check-in;
any acute or chronic condition, scheduled hospitalization (inclusive of elective surgery during study) or scheduled travel prior to completion of all study procedures which, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study;
subjects who, in the opinion of the Investigator, should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit, Inc
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Ethinyl Estradiol/Norgestimate (Ortho Cyclen®), a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

Read the detailed description

This study will be a single center, randomized, open-label, 2 arm study to evaluate the effects of EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy female subjects when EE/norgestimate is administered simultaneously with lomitapide and when administration is separated by 12 hours.

Conditions: Healthy
Being tested: lomitapide, EE/norgestimate
Keywords: Effect, Ethinyl Estradiol/Norgestimate, Pharmacokinetics, Lomitapide.

What participants receive

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

lomitapideDrug
Also called Juxtapid
20 mg
EE/norgestimateDrug
Also called Ortho Cylclen
1x0.035-mg EE/0.25-mg norgestimate tablet

Study groups in NCT02080468
Study group	Role	What they receive
Arm 1: Lomitapide & EE/Norgestimate - Taken Together	Experimental	Lomitapide \& EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28) Receives: Drug: lomitapide; Drug: EE/norgestimate
Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart	Experimental	Lomitapide \& EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29) Receives: Drug: lomitapide; Drug: EE/norgestimate

What is being measured

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

Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Secondary outcomes (5)

Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Apparent terminal elimination half-life of lomitapide and its metabolites, M1 \& M3.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Timeline

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

19 Feb 201424 Apr 2014

First posted6 Mar 2014 (estimated)
Study start19 Feb 2014
Primary completion24 Apr 2014
Study completion24 Apr 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 HealthyStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02080468
Sponsor's protocol ID: AEGR-733-029
Status last verified: Nov 2018
First submitted: 5 Mar 2014
Last updated: 11 Mar 2019
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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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Ethinyl Estradiol/Norgestimate (Ortho Cyclen®), a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
ClinicalTrials.gov ID: NCT02080468
Acronym / sponsor ID: AEGR-733-029
Conditions: Healthy
Keywords: Effect, Ethinyl Estradiol/Norgestimate, Pharmacokinetics, Lomitapide.
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 19 Feb 2014 (actual)
Primary completion: 24 Apr 2014 (actual)
Study completion: 24 Apr 2014 (actual)
First posted: 6 Mar 2014 (estimated)
Results: Posted 11 Mar 2019

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

Arm	Type	Receives
Arm 1: Lomitapide & EE/Norgestimate - Taken Together	Experimental	Drug: lomitapide, Drug: EE/norgestimateLomitapide \& EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28)
Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart	Experimental	Drug: lomitapide, Drug: EE/norgestimateLomitapide \& EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29)

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy females, between 18 and 40 years of age inclusive
BMI between 18.5 and 30.0 kg/m2, inclusive; total body weight of >110 lbs (50 kg);
in good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history and physical exam
no known history of hypersensitivity or previous intolerance to lomitapide or EE/norgestimate
creatine phosphokinase, AST, and ALT levels must be below 1.5 times the upper limit of normal

Key exclusion criteria (20 listed)

significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder
history of unexplained breast abnormalities or abnormal uterine bleeding
history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
history of stomach or intestinal surgery or resection
history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome

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
lomitapideAlso: Juxtapid20 mg	Drug	Arm 1: Lomitapide & EE/Norgestimate - Taken Together, Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart
EE/norgestimateAlso: Ortho Cylclen1x0.035-mg EE/0.25-mg norgestimate tablet	Drug	Arm 1: Lomitapide & EE/Norgestimate - Taken Together, Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart

Primary outcome

Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3
Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 \& M3.
t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \& M3.

5 secondary outcomes

Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Results and safety

Results posted to the registry on 11 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lomitapide & EE/Norgestimate - Taken Together	16	14
Lomitapide & EE/Norgestimate - Taken 12 Hours Apart	16	14

Primary outcome: Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	PK of Lomitapide (Lomitapide Alone) n = 16	PK of Lomitapide (Coadministered Simultaneously) n = 14	PK of M1 (Lomitapide Alone) n = 16	PK of M1 (Coadministered Simultaneously) n = 14	PK of M3 (Lomitapide Alone) n = 16	PK of M3 (Coadministered Simultaneously) n = 14
Value	1.03 (39.1)	1.39 (58.4)	2.96 (27.0)	2.95 (19.4)	36.3 (32.1)	34.0 (27.9)

Population analysed: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Primary outcome: Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing. Median (Full Range). Unit: hr

Measure	PK of Lomitapide (Lomitapide Alone) n = 16	PK of Lomitapide (Coadministered Simultaneously) n = 14	PK of M1 (Lomitapide Alone) n = 16	PK of M1 (Coadministered Simultaneously) n = 14	PK of M3 (Lomitapide Alone) n = 16	PK of M3 (Coadministered Simultaneously) n = 14
Value	6.00 (4.00 to 12.0)	5.00 (1.00 to 18.0)	8.28 (5.00 to 12.0)	6.00 (2.00 to 12.0)	5.02 (3.00 to 12.0)	3.97 (1.00 to 6.00)

Population analysed: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Primary outcome: AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	PK of Lomitapide (Lomitapide Alone) n = 16	PK of Lomitapide (Coadministered Simultaneously) n = 14	PK of M1 (Lomitapide Alone) n = 16	PK of M1 (Coadministered Simultaneously) n = 14	PK of M3 (Lomitapide Alone) n = 16	PK of M3 (Coadministered Simultaneously) n = 14
Value	33.5 (35.0)	42.7 (49.5)	89.3 (35.6)	96.8 (32.1)	456 (41.2)	371 (36.1)

Population analysed: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Primary outcome: AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	PK of Lomitapide (Lomitapide Alone) n = 16	PK of Lomitapide (Coadministered Simultaneously) n = 14	PK of M1 (Lomitapide Alone) n = 16	PK of M1 (Coadministered Simultaneously) n = 14	PK of M3 (Lomitapide Alone) n = 16	PK of M3 (Coadministered Simultaneously) n = 14
Value	36.5 (34.8)	46.5 (49.1)	91.4 (35.8)	99.4 (32.4)	463 (40.9)	377 (36.0)

Population analysed: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lomitapide & EE/Norgestimate - Taken Together	0 of 16 (0%)	8 of 16 (50%)	0 of 16
Lomitapide & EE/Norgestimate - Taken 12 Hours Apart	0 of 16 (0%)	7 of 16 (43.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
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.

Mark Sumeray, MD study chair

Cheif Medical Officer

T. Alex King, MD, CPI principal investigator

Covance

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 lomitapide and EE/norgestimate in people with Healthy, run by Aegerion Pharmaceuticals, Inc. 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 20 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 11 Mar 2019. 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 11 Mar 2019). 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?

Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) (time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing). The study lists 5 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 NCT02080468.

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 11 Mar 2019.