Diabetic Kidney DiseasePhase 1NCT02509624

Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function

A Phase 1 study testing Selonsertib in people with Diabetic Kidney Disease, run by Gilead Sciences at 5 sites 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 primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetic Kidney Disease
What is being tested?: Selonsertib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 5 sitesUnited States
Study dates: 18 Aug 2015to 15 Dec 2015
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All participants:
Body mass index (BMI) from 18 to 40 kg/m^2, inclusive at study screening
Creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening
Participants with impaired hepatic function:
Aside from hepatic insufficiency, participants must be sufficiently healthy for study participation based upon screening evaluations.
Must have diagnosis of chronic (> 6 months), stable hepatic impairment with no clinically significant change in hepatic status within the 3 months (90 days) prior to study drug administration (Day 1).

Show all 11Show fewer

Participants with severe hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 10-15 at screening.
Participants with moderate hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 7-9 at screening.
Participants with mild hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 5-6 at screening.
Healthy participants (matched control):
Must be in good health based upon screening evaluations.

Who cannot join

All participants:
Pregnant or lactating females
Have received any investigational compound or device within 30 days prior to study dosing
Current alcohol or substance abuse
A positive test result for human immunodeficiency virus (HIV-1/2) antibody
Have poor venous access that limits phlebotomy

Show all 34Show fewer

Have been treated with systemic steroids, anti-HIV agents, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) that would be contraindicated for other exclusion criteria.
Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
Unstable cardiac disease, including history of myocardial infarction within 1 year of screening, recurrent episodes of ventricular tachycardia despite appropriate medical therapy, decompensated congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40%, or a family history of Long QT Syndrome, or unexplained death in an otherwise healthy participants between the ages of 1 and 30 years.
Syncope, palpitations, or unexplained dizziness
Implanted defibrillator or pacemaker
Severe peptic ulcer disease, severe gastroesophageal reflux disease, or other severe gastric acid hypersecretory conditions
Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary.
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
Currently registered on an organ transplantation list.
History of bleeding from esophageal varices within 90 days prior to Admission (Day -1).
Use of strong cytochrome P3A4 (CYP3A4) inhibitors (eg, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone, telithromycin, atazanavir) and strong CYP3A4 inducers (eg, carbamazepine, rifampin, phenytoin and St. John's wort), within 28 days prior to study drug administration (Day 1).
Consumption of grapefruit juice, grapefruits, and Seville orange juice within 2 weeks prior to study drug administration (Day 1).
Recent significant changes in the use of nicotine or nicotine containing products
Participants with impaired hepatic function:
Aside from hepatic insufficiency, serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol.
Chronic hepatitis B virus (HBV) infection, defined as a positive test for hepatitis B surface antigen (HBsAg), unless the participant has been treated with a nucleos(t)ide analog (eg, tenofovir or entecavir) for at least 6 months and the HBV deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) assay has been persistently undetectable for at least 6 months.
Positive test for drugs of abuse, including alcohol at screening or on Day -1/check-in, with the exception of opioids and tetrahydrocannabinol (THC, marijuana) under prescription and investigator verification for pain management. Participants who screen positive for benzodiazepines may be allowed if prescribed under the care of a physician and after review by investigator and Sponsor.
Requires paracentesis > 1 time per month.
Participants with hepatic impairment with co-morbid diseases not associated with hepatic impairment requiring medication(s) must be taking the medication(s) without a change in dose for > 3 months prior to screening.
Changes in concomitant medications or dosage used to treat symptoms of hepatic impairment or associated co-morbid conditions that could lead to clinically significant changes in medical conditions during the course of the study that would affect the ability to interpret potential drug-drug interactions within 28 days prior to dosing.
Healthy participants (matched control):
A positive test result for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (anti-HBc)
Positive test for drugs of abuse, including alcohol at screening or on Day -1/check-in.
Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol.
History of liver disease.
Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins, acetaminophen, ibuprofen, and hormonal contraceptive medications.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study site
Denver, Colorado
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
Orlando, Florida
Study site
San Antonio, Texas

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Parallel-Group, Single Dose Study to Evaluate the Pharmacokinetics of GS-4997 in Subjects With Normal and Impaired Hepatic Function

The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.

Conditions: Diabetic Kidney Disease
Being tested: Selonsertib
Medical subject headings: Diabetic Nephropathies

What participants receive

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

SelonsertibDrug
Also called GS-4997
6 mg tablets administered orally in fed state

Study groups in NCT02509624
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 selonsertib on Day 1. Receives: Drug: Selonsertib
Severe hepatic impairment (Cohort 2)	Experimental	Participants with severe hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. Receives: Drug: Selonsertib
Mild hepatic impairment (Cohort 3)	Experimental	Participants with mild hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1. Receives: Drug: Selonsertib

What is being measured

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

Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Measured: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509
Cmax is defined as the maximum concentration of drug.
Measured: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.

Secondary outcomes (2)

Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs were defined as events that met one of the following criteria: 1) Any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; or 2) Any AEs leading to premature discontinuation of study drug.
Measured: Day 1 plus 30 days
Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from predose at any postdose visit, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study drug. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent. Severity grades were defined based on modified Common Terminology Criteria for Adverse Events (CTCAE) Laboratory Abnormality and Adverse Event Severity Grading, where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. The most severe graded abnormality from all tests was counted for each participant.
Measured: Day 1 plus 30 days

Timeline

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

18 Aug 201515 Dec 2015

First posted28 Jul 2015 (estimated)
Study start18 Aug 2015
Primary completion15 Dec 2015
Study completion15 Dec 2015

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 Diabetic Kidney DiseaseStudies 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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02509624
Sponsor's protocol ID: GS-US-223-1018
Other IDs: 2015-002444-14, 2015
Status last verified: Jan 2021
First submitted: 16 Jul 2015
Last updated: 27 Jan 2021
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

Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)

All Diabetic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Parallel-Group, Single Dose Study to Evaluate the Pharmacokinetics of GS-4997 in Subjects With Normal and Impaired Hepatic Function
ClinicalTrials.gov ID: NCT02509624
Acronym / sponsor ID: GS-US-223-1018
Conditions: Diabetic Kidney Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 18 Aug 2015 (actual)
Primary completion: 15 Dec 2015 (actual)
Study completion: 15 Dec 2015 (actual)
First posted: 28 Jul 2015 (estimated)
Results: Posted 27 Jan 2021

Clinical summary

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

The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.

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: SelonsertibParticipants with moderate hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1.
Severe hepatic impairment (Cohort 2)	Experimental	Drug: SelonsertibParticipants with severe hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1.
Mild hepatic impairment (Cohort 3)	Experimental	Drug: SelonsertibParticipants with mild hepatic impairment and matched healthy controls will receive a single dose of selonsertib on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Body mass index (BMI) from 18 to 40 kg/m^2, inclusive at study screening
Creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening
Aside from hepatic insufficiency, participants must be sufficiently healthy for study participation based upon screening evaluations.
Must have diagnosis of chronic (> 6 months), stable hepatic impairment with no clinically significant change in hepatic status within the 3 months (90 days) prior to study drug administration (Day 1).
Participants with severe hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 10-15 at screening.

Key exclusion criteria (34 listed)

Pregnant or lactating females
Have received any investigational compound or device within 30 days prior to study dosing
Current alcohol or substance abuse
A positive test result for human immunodeficiency virus (HIV-1/2) antibody
Have poor venous access that limits phlebotomy

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
SelonsertibAlso: GS-49976 mg tablets administered orally in fed state	Drug	Mild hepatic impairment (Cohort 3), Moderate hepatic impairment (Cohort 1), Severe hepatic impairment (Cohort 2)

Primary outcome

Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
AUCinf is defined as the concentration of drug extrapolated to infinite time.
PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
Cmax is defined as the maximum concentration of drug.

2 secondary outcomes

Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs)
Time frame: Day 1 plus 30 days
Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities
Time frame: Day 1 plus 30 days

Results and safety

Results posted to the registry on 27 Jan 2021, 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 1: Moderate Hepatic Impairment	10	10
Cohort 2: Severe Hepatic Impairment	10	10
Cohort 3: Mild Hepatic Impairment	10	10
Healthy Control	22	22

Primary outcome: Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509

Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Cohort 1: Moderate Hepatic Impairment n = 10	Cohort 2: Severe Hepatic Impairment n = 10	Cohort 3: Mild Hepatic Impairment n = 10	Matched Healthy Control for Cohort 1 n = 10	Matched Healthy Control for Cohort 2 n = 10	Matched Healthy Control for Cohort 3 n = 10
AUCinf of Selonsertib	3316.1 (1734.11)	3266.7 (766.39)	2962.1 (901.12)	2835.3 (499.58)	2277.9 (490.96)	2711.6 (919.83)
AUCinf of GS-607509	5941.8 (2286.80)	5711.2 (3401.94)	10203.6 (8689.39)	9993.3 (4599.91)	9603.4 (8057.84)	9846.6 (8954.40)

Cohort 1: Moderate Hepatic Impairment vs Matched Healthy Control for Cohort 1: %Geometric least-square mean(GLSM) ratio: 105.08 (90% CI 77.08 to 143.23)
Cohort 2: Severe Hepatic Impairment vs Matched Healthy Control for Cohort 2: % GLSM ratio: 142.65 (90% CI 120.52 to 168.84)
Cohort 3: Mild Hepatic Impairment vs Matched Healthy Control for Cohort 3: % GLSM ratio: 110.55 (90% CI 86.99 to 140.49)

Population analysed: PK Analysis Set included all enrolled participants who received at least 1 dose of selonsertib and had at least 1 evaluable PK concentration data value reported by the PK laboratory for the respective analytes. 3 participants served as matched control in both Cohort 1 and 2. 1 participant served as a matched control in both Cohort 1 and 3. 4 participants served as matched control in both Cohort 2 and 3.

Primary outcome: PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509

Measure	Cohort 1: Moderate Hepatic Impairment n = 10	Cohort 2: Severe Hepatic Impairment n = 10	Cohort 3: Mild Hepatic Impairment n = 10	Matched Healthy Control for Cohort 1 n = 10	Matched Healthy Control for Cohort 2 n = 10	Matched Healthy Control for Cohort 3 n = 10
AUClast of Selonsertib	2964.1 (1493.69)	3032.7 (728.55)	2790.8 (847.18)	2679.9 (486.23)	2129.7 (493.83)	2530.9 (902.55)
AUClast of GS-607509	5405.2 (2211.86)	4868.0 (3072.43)	8475.8 (7165.86)	9117.6 (4127.22)	8157.5 (6019.61)	8326.5 (6604.26)

Cohort 1: Moderate Hepatic Impairment vs Matched Healthy Control for Cohort 1: % GLSM ratio: 99.87 (90% CI 73.38 to 135.92)
Cohort 2: Severe Hepatic Impairment vs Matched Healthy Control for Cohort 2: % GLSM ratio: 141.75 (90% CI 118.50 to 169.55)
Cohort 3: Mild Hepatic Impairment vs Matched Healthy Control for Cohort 3: % GLSM ratio: 112.24 (90% CI 87.69 to 143.65)

Population analysed: Participants in the PK Analysis Set were analyzed. 3 participants served as matched control in both Cohort 1 and 2. 1 participant served as a matched control in both Cohort 1 and 3. 4 participants served as matched control in both Cohort 2 and 3.

Primary outcome: PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509

Measure	Cohort 1: Moderate Hepatic Impairment n = 10	Cohort 2: Severe Hepatic Impairment n = 10	Cohort 3: Mild Hepatic Impairment n = 10	Matched Healthy Control for Cohort 1 n = 10	Matched Healthy Control for Cohort 2 n = 10	Matched Healthy Control for Cohort 3 n = 10
Cmax of Selonsertib	93.7 (20.66)	82.4 (10.63)	110.6 (24.77)	105.4 (22.13)	91.9 (22.01)	110.3 (23.40)
Cmax of GS-607509	44.1 (15.01)	31.2 (15.34)	63.5 (31.42)	62.3 (23.44)	63.2 (27.03)	64.2 (21.99)

Cohort 1: Moderate Hepatic Impairment vs Matched Healthy Control for Cohort 1: % GLSM ratio: 88.68 (90% CI 74.83 to 105.10)
Cohort 2: Severe Hepatic Impairment vs Matched Healthy Control for Cohort 2: % GLSM ratio: 91.16 (90% CI 78.76 to 105.52)
Cohort 3: Mild Hepatic Impairment vs Matched Healthy Control for Cohort 3: % GLSM ratio: 100.19 (90% CI 83.73 to 119.88)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Moderate Hepatic Impairment	0 of 10 (0%)	3 of 10 (30%)	Not reported
Cohort 2: Severe Hepatic Impairment	0 of 10 (0%)	0 of 10 (0%)	Not reported
Cohort 3: Mild Hepatic Impairment	0 of 10 (0%)	2 of 10 (20%)	Not reported
Healthy Control	0 of 22 (0%)	2 of 22 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Kidney Disease

Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)

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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Selonsertib in people with Diabetic Kidney Disease, run by Gilead Sciences at 5 sites 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 11 inclusion and 34 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 27 Jan 2021). 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?

Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509 (time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.). The study lists 3 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 NCT02509624.

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 27 Jan 2021.