Long QT SyndromePhase 1NCT02412098

Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function

A Phase 1 study testing Eleclazine in people with Long QT Syndrome, run by Gilead Sciences at 7 sites in 4 countries.

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Long QT Syndrome
What is being tested?: Eleclazine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 7 sitesin 4 countries
Study dates: 19 Mar 2015to 22 Apr 2016
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

All participants:
Be a nonsmoker or consume < 20 cigarettes per day
Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at study screening
Have a creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening
Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
Screening labs within defined thresholds

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Participants with mild, moderate, or severe hepatic impairment must also meet the following additional inclusion criteria:
Must have diagnosis of chronic (> 6 months), stable hepatic impairment with no clinically significant changes within 3 months (90 days) prior to study drug administration (Day 1)
Individuals with severe hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 10-15 at screening. If an individual's score changes during the course of the study, the score at screening will be used for classification.
Individuals with moderate hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 7-9 at screening. If an individual's score changes during the course of the study, the score at Screening will be used for classification.
Individuals with mild hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 5-6 at screening. If an individual's score changes during the course of the study, the score at screening will be used for classification.

Who cannot join

Pregnant or lactating females
History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors, myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries or a family history of seizures
Presence or history of cardiovascular disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection fraction < 40%), cardiac conduction abnormalities, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
Syncope, palpitations, or unexplained dizziness
Implanted defibrillator or pacemaker
Are unable to comply with study requirements or are otherwise believed, by the study investigator, to be inappropriate for study participation for any reason

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Participants with mild, moderate, or severe hepatic impairment must also meet the following additional exclusion criteria:
Active hepatitis B virus (HBV) infection. Individuals who have HBsAg are ineligible
Requires paracentesis > 1 time per month
Severe (grade 3 or 4) encephalopathy as judged by the investigator
History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures

Trial locations and contacts

7 sites in 4 countries.

Country

City, postcode or hospital

7 sites in 4 countries

United States4 sites

Study site
Kansas City, Missouri
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
Orlando, Florida

Other trials in United States

Germany1 site

Study site
München

Other trials in Germany

New Zealand1 site

Study site
Auckland

Other trials in New Zealand

Romania1 site

Study site
Bucharest

Other trials in Romania

About this study

Official title: A Phase 1, Open-Label, Parallel-Group, Adaptive, Single Dose Study to Evaluate the Pharmacokinetics of GS-6615 in Subjects With Normal and Impaired Hepatic Function

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral eleclazine and its metabolite, GS-623134, in participants with normal and impaired hepatic function. Participants in the healthy control group will be matched to participants with impaired hepatic function by age (± 5 years), gender, and body mass index (± 10%).

Conditions: Long QT Syndrome
Being tested: Eleclazine
Keywords: Hepatic Impairment
Medical subject headings: Long QT Syndrome

What participants receive

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

EleclazineDrug
Also called GS-6615
Eleclazine tablets administered orally

Study groups in NCT02412098
Study group	Role	What they receive
Moderate Hepatic Impairment (Cohort 1)	Experimental	Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). Receives: Drug: Eleclazine
Severe Hepatic Impairment (Cohort 2)	Experimental	Participants with severe hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). Receives: Drug: Eleclazine
Mild Hepatic Impairment (Cohort 3)	Experimental	Participants with mild hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). Receives: Drug: Eleclazine

What is being measured

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

PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine
AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57
PK Parameter: AUCinf of GS-623134 (Metabolite of Eleclazine)
AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57
PK Parameter: Cmax of Eleclazine
Cmax was defined as the maximum observed concentration of drug in plasma.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57
PK Parameter: Cmax of GS-623134 (Metabolite of Eleclazine)
Cmax was defined as the maximum observed concentration of drug in plasma.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57

Secondary outcomes (2)

Number of Participants Experiencing Treatment-Emergent Adverse Events
Treatment-emergent adverse events (AEs) are defined as one or both of the following:
- Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
- Any AEs leading to premature discontinuation of study drug.
Measured: First dose date up to 31 days
Number of Participants Experiencing Clinical Laboratory Abnormalities
Treatment-emergent laboratory abnormalities reported as an adverse event (AE) or serious adverse event (SAE) are presented. Laboratory abnormalities that required medical or surgical intervention or led to study drug interruption, modification, or discontinuation were recorded as an AE or SAE, as applicable, and are reported here. Laboratory abnormalities without clinical significance were not recorded as AEs or SAEs and therefore, are not being reported.
Measured: First dose date up to 31 days

Timeline

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

19 Mar 201522 Apr 2016

First posted8 Apr 2015 (estimated)
Study start19 Mar 2015
Primary completion22 Apr 2016
Study completion22 Apr 2016

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 Long QT SyndromeStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02412098
Sponsor's protocol ID: GS-US-372-1048
Other IDs: 2014-005266-30, 2014
Status last verified: May 2019
First submitted: 11 Mar 2015
Last updated: 29 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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 Long QT Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Parallel-Group, Adaptive, Single Dose Study to Evaluate the Pharmacokinetics of GS-6615 in Subjects With Normal and Impaired Hepatic Function
ClinicalTrials.gov ID: NCT02412098
Acronym / sponsor ID: GS-US-372-1048
Conditions: Long QT Syndrome
Keywords: Hepatic Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 19 Mar 2015 (actual)
Primary completion: 22 Apr 2016 (actual)
Study completion: 22 Apr 2016 (actual)
First posted: 8 Apr 2015 (estimated)
Results: Posted 29 Jul 2019

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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Moderate Hepatic Impairment (Cohort 1)	Experimental	Drug: EleclazineParticipants with moderate hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).
Severe Hepatic Impairment (Cohort 2)	Experimental	Drug: EleclazineParticipants with severe hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).
Mild Hepatic Impairment (Cohort 3)	Experimental	Drug: EleclazineParticipants with mild hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).

Who may qualify

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

Key inclusion criteria (11 listed)

Be a nonsmoker or consume < 20 cigarettes per day
Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at study screening
Have a creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening
Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
Screening labs within defined thresholds

Key exclusion criteria (11 listed)

Pregnant or lactating females
History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors, myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries or a family history of seizures
Presence or history of cardiovascular disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection fraction < 40%), cardiac conduction abnormalities, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
Syncope, palpitations, or unexplained dizziness
Implanted defibrillator or pacemaker

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
EleclazineAlso: GS-6615Eleclazine tablets administered orally	Drug	Mild Hepatic Impairment (Cohort 3), Moderate Hepatic Impairment (Cohort 1), Severe Hepatic Impairment (Cohort 2)

Primary outcome

PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57
AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
PK Parameter: AUCinf of GS-623134 (Metabolite of Eleclazine)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57
AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
PK Parameter: Cmax of Eleclazine
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57
Cmax was defined as the maximum observed concentration of drug in plasma.
PK Parameter: Cmax of GS-623134 (Metabolite of Eleclazine)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57
Cmax was defined as the maximum observed concentration of drug in plasma.

2 secondary outcomes

Number of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: First dose date up to 31 days
Number of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 31 days

Results and safety

Results posted to the registry on 29 Jul 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
Moderate Hepatic Impairment (Cohort 1)	14	14
Mild Hepatic Impairment (Cohort 3)	14	14
Normal Hepatic Function	21	21

Primary outcome: PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine

Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57. Geometric mean (95% Confidence Interval). Unit: h*ng/mL

Measure	Moderate Hepatic Impairment (Cohort 1) n = 14	Mild Hepatic Impairment (Cohort 3) n = 14	Normal Hepatic Function (Matched Control for Cohort 1) n = 14	Normal Hepatic Function (Matched Control for Cohort 3) n = 14
Value	42503.2 (23983.8 to 75322.7)	50064.7 (31758.4 to 78923.2)	57795.9 (37994.2 to 87917.5)	39173.2 (23050.5 to 66573.2)

Moderate Hepatic Impairment (Cohort 1) vs Normal Hepatic Function (Matched Control for Cohort 1): Geometric Least Square Mean (GLSM) Ratio: 73.54 (90% CI 41.92 to 129.01)
Mild Hepatic Impairment (Cohort 3) vs Normal Hepatic Function (Matched Control for Cohort 3): GLSM Ratio (%): 127.80 (90% CI 73.57 to 222.01)

Population analysed: PK Analysis Set included all enrolled participants who received at least one dose of eleclazine and had at least one evaluable PK concentration value reported by the PK laboratory for the corresponding analyte. Healthy control participants may participate in more than one cohorts.

Primary outcome: PK Parameter: AUCinf of GS-623134 (Metabolite of Eleclazine)

Measure	Moderate Hepatic Impairment (Cohort 1) n = 7	Mild Hepatic Impairment (Cohort 3) n = 10	Normal Hepatic Function (Matched Control for Cohort 1) n = 8	Normal Hepatic Function (Matched Control for Cohort 3) n = 12
Value	1880.0 (980.5 to 3604.4)	1983.2 (1238.3 to 3176.0)	2326.2 (1497.0 to 3614.9)	2697.4 (2023.1 to 3596.5)

Moderate Hepatic Impairment (Cohort 1) vs Normal Hepatic Function (Matched Control for Cohort 1): GLSM Ratio (%): 80.82 (90% CI 45.11 to 144.79)
Mild Hepatic Impairment (Cohort 3) vs Normal Hepatic Function (Matched Control for Cohort 3): GLSM Ratio (%): 73.52 (90% CI 47.83 to 113.02)

Population analysed: Participants in the PK Analysis Set with available data were analyzed. Healthy control participants may participate in more than one cohorts.

Primary outcome: PK Parameter: Cmax of Eleclazine

Measure	Moderate Hepatic Impairment (Cohort 1) n = 14	Mild Hepatic Impairment (Cohort 3) n = 14	Normal Hepatic Function (Matched Control for Cohort 1) n = 14	Normal Hepatic Function (Matched Control for Cohort 3) n = 14
Value	214.9 (169.4 to 272.5)	338.1 (283.6 to 403.1)	322.9 (279.4 to 373.1)	331.3 (273.1 to 401.9)

Moderate Hepatic Impairment (Cohort 1) vs Normal Hepatic Function (Matched Control for Cohort 1): GLSM Ratio (%): 66.55 (90% CI 53.33 to 83.04)
Mild Hepatic Impairment (Cohort 3) vs Normal Hepatic Function (Matched Control for Cohort 3): GLSM Ratio (%): 102.06 (90% CI 83.03 to 125.45)

Population analysed: Participants in the PK Analysis Set were analyzed. Healthy control participants may participate in more than one cohorts.

Primary outcome: PK Parameter: Cmax of GS-623134 (Metabolite of Eleclazine)

Measure	Moderate Hepatic Impairment (Cohort 1) n = 11	Mild Hepatic Impairment (Cohort 3) n = 13	Normal Hepatic Function (Matched Control for Cohort 1) n = 14	Normal Hepatic Function (Matched Control for Cohort 3) n = 14
Value	4.9 (3.2 to 7.7)	7.3 (4.6 to 11.4)	6.5 (5.0 to 8.4)	10.2 (7.0 to 15.0)

Moderate Hepatic Impairment (Cohort 1) vs Normal Hepatic Function (Matched Control for Cohort 1): GLSM Ratio (%): 76.24 (90% CI 50.65 to 114.77)
Mild Hepatic Impairment (Cohort 3) vs Normal Hepatic Function (Matched Control for Cohort 3): GLSM Ratio (%): 71.06 (90% CI 44.59 to 113.25)

Population analysed: Participants in the PK Analysis Set with available data were analyzed. Healthy control participants may participate in more than one cohorts.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date up to 31 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate Hepatic Impairment	0 of 14 (0%)	6 of 14 (42.9%)	0 of 14
Mild Hepatic Impairment	0 of 14 (0%)	8 of 14 (57.1%)	0 of 14
Normal Hepatic Function	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 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.

Gilead Study Director study director

Gilead Sciences

7 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eleclazine in people with Long QT Syndrome, run by Gilead Sciences at 7 sites in 4 countries.

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 11 inclusion and 11 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 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Germany, New Zealand, Romania. 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 29 Jul 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?

PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine (time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57). 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 NCT02412098.

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 29 Jul 2019.