Hepatitis CPhase 1NCT01277692

A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.

A Phase 1 study testing GSK2336805 10mg, GSK2336805 30mg and GSK2236805 100mg in people with Hepatitis C, run by GlaxoSmithKline at 3 sites 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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C
What is being tested?: GSK2336805 10mg, GSK2336805 30mg and GSK2236805 100mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 3 sitesUnited States
Study dates: 3 Nov 2010to 9 May 2011
Phase: Phase 1
Are there results?: None posted in the registry

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

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG, including no cardiac, pulmonary, hepatic, biliary (except Gilbert's disease, gastrointestinal, or renal (defined as serum creatinine >1.5 mg/dL or a calculated creatinine clearance (CrCl)<50 mL/min), disorders, or cancer within the past 5 years (except localized or in situ cancer of the skin). A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat laboratory evaluation is allowed for eligibility determination.
Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
A female is eligible to enter and participate in this study if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral oophorectomy, hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
Male subjects must agree to use one of the contraception methods listed in the protocol.
Body weight greater than or equal to 50 kg (110 lbs.) for men and greater than or equal to 45 kg (99 lbs.) for women. For Part 1, body mass index (BMI) between 18.5-32 kg/m2 inclusive will be allowed. For Part 3, BMI between 18.5-35.0 kg/m2 inclusive will be allowed.
For healthy subjects in Part 1 and Part 2, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase, bilirubin, and creatinine less than the upper limits of normal (ULN) (isolated bilirubin <2.0xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

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QTcB or QTcF < 450 msec; or QTc <480 msec in subjects with Bundle Branch Block.
The subject's systolic blood pressure is inside the range of 90-140 mmHg, or diastolic blood pressure is inside the range of 45-90 mmHg or heart rate is inside the range of 50-100 beats per minute (bpm) for female subjects or 45-100 bpm for male subjects.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.
The following are Supplemental inclusion criteria for Part 3: HCV positive subjects: Treatment naive chronically infected genotype 1 HCV patients, defined as infection for >6 months and no prior HCV therapy.
An HCV RNA viral load of greater than 100,000 IU/mL using a COBAS TaqMan HCV test and HCV genotype 1a or 1b as assessed by VERSANT HCV genotyping LiPA 2.0 (Bayer Healthcare, Berkeley, California), or by direct Deoxyribonucleic acid (DNA) sequencing of the NS5B gene Hepatitis C virus infection of mixed genotype excluded. HCV subjects with mixed genotypes are not eligible for the study.
ALT greater than or equal to 3x ULN is allowed.
Liver biopsy within two years prior to screening indicating the absence of cirrhosis.

Who cannot join

Unwillingness or inability to follow the procedures outlined in the protocol.
A positive pre-study test for Human Immunodeficiency Virus (HIV) antibody or Hepatitis B surface antigen.
For healthy subjects in Parts 1 and 2, a positive Hepatitis C antibody result within 3 months of screening. Chronic HCV infected subjects in Part 3 will have a positive HCV antibody and a positive HCV RNA.
Pregnant females as determined by positive serum or urine Human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Subject is mentally or legally incapacitated.
Has a history of regular alcohol consumption averaging: >7 drinks/week for women or >14 drinks/week for men within 6 months of the screening visit.

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Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
For healthy subjects in Parts 1 and 2, history of regular use of tobacco- or nicotine-containing products within 3 months of the screening visit or indication of tobacco use as evidenced by a positive urine cotinine test at screening. For chronic HCV infected subjects in Part 3, history of regular use of tobacco- or nicotine-containing products is allowed; however, use of tobacco is not allowed on days of PK draws nor at the study site.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, satsuma, ugli, tangerine, and tangelo, exotic citrus fruits, grapefruit hybrids or fruit juices from 5 days prior to the first dose of study medication.
The subject has a positive pre-study drug screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, phencyclidine (PCP), and benzodiazepines. Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new investigational entities within 12 months prior to the first dosing day.
History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Holter monitoring shows one or more of the following: Any symptomatic arrhythmia (except isolated extra systoles); Sustained cardiac arrhythmias (such as atrial fibrillation or flutter, sustained ventricular tachycardia (SVT) (>10 consecutive beats)); Non-sustained or sustained ventricular tachycardia (defined as >3 consecutive ventricular ectopic beats); Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular (AV) block [2nd degree or higher in an awake subject], Wolff-Parkinson-White syndrome (WPW) syndrome, other pre-excitation syndromes); Symptomatic sinus pause or sinus pause >3 seconds - unless patient is straining, vomiting, or having some other type of hypervagal response; 300 or more supraventricular ectopic beats in 24 hours; 250 or more ventricular ectopic beats in 24 hours; Ischemia, diagnosed by a sequence of EKG changes that include flat or down sloping ST-segment depression >0.1 mV, with a gradual onset and offset that lasts for a minimum period of 1 minute. Each episode of ischemia must be separated by a minimum duration of at least 1 minute, during which the ST segment returns back to baseline (1x1x1 rule)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

GSK Investigational Site
Chula Vista, California, 91911
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Willingboro, New Jersey, 08046

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Dose Escalation, Fusion, First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Subjects

This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled, double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2) iii. Single doses in chronically infected HCV positive subjects (Part 3).

Conditions: Hepatitis C
Being tested: GSK2336805 10mg, GSK2336805 30mg, GSK2236805 100mg, GSK2236805 200mg, GSK2236805 10mg
Keywords: First administration to human, safety, pharmacokinetics, healthy subjects, antiviral activity, hepatitis C patients
Medical subject headings: Hepatitis C

What participants receive

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

GSK2336805 10mgDrug
single dose once daily
GSK2336805 30mgDrug
single dose once daily
GSK2236805 100mgDrug
single dose once daily
GSK2236805 200mgDrug
single dose once daily
GSK2236805 10mgDrug
repeat dose once daily for 7 days
GSK2236805 dose to be determined up to 100mgDrug
repeat dose once daily for 7 days
GSK2236805 5mgDrug
single dose in HCV infected patients
GSK2236805 30mgDrug
single dose in HCV infected patients
GSK2236805 100mgDrug
single dose in HCV infected patients

Study groups in NCT01277692
Study group	Role	What they receive
Part 1: Single Dose Escalation in Healthy Subjects	Experimental	The doses currently planned are 10, 30mg, 100mg, 200mg Receives: Drug: GSK2336805 10mg; Drug: GSK2336805 30mg; Drug: GSK2236805 100mg; Drug: GSK2236805 200mg
Part 2: Repeat Dose Escalation in Healthy Subjects	Experimental	The first planned dose is currently 10mg QD and the planned maximum dose is 100mg QD Receives: Drug: GSK2236805 10mg; Drug: GSK2236805 dose to be determined up to 100mg
Part 3: Single Dose Escalation in HCV Infected Subjects	Experimental	The planned doses for Part 3 are 5mg, 30mg, and 100 mg. Receives: Drug: GSK2236805 5mg; Drug: GSK2236805 30mg; Drug: GSK2236805 100mg

What is being measured

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

GSK2336805 safety parameters : adverse events
Measured: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: telemetry
Measured: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: absolute values and changes over time of hematology, clinical chemistry, urinalysis
Measured: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: vital signs (blood pressure, heart rate)
Measured: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: electrocardiogram (ECG) parameters
Measured: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve over the dosing interval AUC(0-tau))
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: maximum observed concentration (Cmax)
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: time to maximum observed concentration (tmax)
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: observed concentration at 24h post-dose (C24)
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: terminal half-life (t1/2)
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: lag time (tlag)
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: apparent clearance (CL/F)
Measured: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following repeat dose administration:AUC(0-tau)
Measured: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: Pre-dose (trough) concentration at the end of the dosing interval Ctau
Measured: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: Cmax
Measured: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: tmax
Measured: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: t1/2,
Measured: Day 7 and day 14
GSK2336805 PK parameters following repeat dose administration: CL/F
Measured: Day 7 and Day 14
GSK2336805 PK parameters following single dose in HCV infected subjects: AUC(0-infinity) or AUC(0 - tau)
Measured: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: Cmax
Measured: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: C24
Measured: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: tmax
Measured: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: tlag
Measured: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: CL/F
Measured: for 48 hours
HCV Ribonucleic acid (RNA) viral load reduction from baseline during the 24hr and post-dosing following a single dose of GSK2336805 in HCV subjects
Measured: at baseline, 24 hours, and for 16 days
HCV RNA change from baseline to nadir (maximum change) in HCV subjects
Measured: baseline, and for 16 days
Time course of HCV viral load at baseline, after dosing with GSK2336805, and for greater than or equal to 2 weeks after GSK2336805 dosing (Part 3)
Measured: baseline and up to 16 days

Secondary outcomes (12)

GSK2336805 PK parameters: AUC(0-infinity) or AUC (0 - tau) following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Measured: 48 hours
GSK2336805 PK parameters: Cmax following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Measured: 48 hours
GSK2336805 PK parameters: tmax following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Measured: 48 hours
GSK2336805 PK parameters: tlag following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Measured: 48 hours
GSK2336805 AUC(0-tau) on Day 7 compared to AUC(0-24) on Day 1 to estimate accumulation ratio (R) and GSK2336805 AUC(0-tau) on Day 7 compared to AUC(0-infinity) on Day 1
Measured: Day 1 and Day 7
Pre-dose concentrations (Ctau) on Day 2 through 7 to assess the achievement of steady state of GSK2336805 following repeat administration (Part 2)
Measured: Day 2 through Day 7
GSK2336805 PK parameters: AUC(0-infinity), AUC(0-t), Cmax, and C24 following single dose administration
Measured: 48 hours
GSK2336805 PK parameters: AUC(0-τ), Cτ, and Cmax following repeat administration
Measured: for 7 days
Correlation between concentration and various safety parameters, if appropriate
Measured: 16 days
Sequence analysis of the viral quasispecies as appropriate (Part 3).
Measured: 16 days
GSK2336805 AUC(0-tau) on Day 14 compared to AUC(0-24) on Day 1 to estimate accumulation ratio (R) and GSK2336805 AUC(0-tau) on Day 14 compared to AUC(0-inf) on Day 1
Measured: 14 days
Pre-dose concentrations (Ctau) on Day 2 through 14 to assess the achievement of steady state of GSK2336805 following repeat administration (Part 2 Cohort E)
Measured: Day 2 and Day 14

Timeline

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

3 Nov 20109 May 2011

First posted17 Jan 2011 (estimated)
Study start3 Nov 2010
Primary completion9 May 2011
Study completion9 May 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Other
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01277692
Sponsor's protocol ID: 114885
Status last verified: Jun 2017
First submitted: 13 Jan 2011
Last updated: 28 Jun 2017
Results posted: No
Data monitoring committee: No

Publications

Wilfret DA, Walker J, Adkison KK, Jones LA, Lou Y, Gan J, Castellino S, Moseley CL, Horton J, de Serres M, Culp A, Goljer I, Spreen W. Safety, tolerability, pharmacokinetics, and antiviral activity of GSK2336805, an inhibitor of hepatitis C virus (HCV) NS5A, in healthy subjects and subjects chronically infected with HCV genotype 1. Antimicrob Agents Chemother. 2013 Oct;57(10):5037-44. doi: 10.1128/AAC.00910-13. Epub 2013 Jul 29.
PubMed 23896477

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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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Dose Escalation, Fusion, First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Subjects
ClinicalTrials.gov ID: NCT01277692
Acronym / sponsor ID: 114885
Conditions: Hepatitis C
Keywords: First administration to human, safety, pharmacokinetics, healthy subjects, antiviral activity, hepatitis C patients
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Nov 2010 (actual)
Primary completion: 9 May 2011 (actual)
Study completion: 9 May 2011 (actual)
First posted: 17 Jan 2011 (estimated)
Results: Not posted in the source record

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: Other
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Part 1: Single Dose Escalation in Healthy Subjects	Experimental	Drug: GSK2336805 10mg, Drug: GSK2336805 30mg, Drug: GSK2236805 100mg, Drug: GSK2236805 200mgThe doses currently planned are 10, 30mg, 100mg, 200mg
Part 2: Repeat Dose Escalation in Healthy Subjects	Experimental	Drug: GSK2236805 10mg, Drug: GSK2236805 dose to be determined up to 100mgThe first planned dose is currently 10mg QD and the planned maximum dose is 100mg QD
Part 3: Single Dose Escalation in HCV Infected Subjects	Experimental	Drug: GSK2236805 5mg, Drug: GSK2236805 30mg, Drug: GSK2236805 100mgThe planned doses for Part 3 are 5mg, 30mg, and 100 mg.

Who may qualify

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

Key inclusion criteria (14 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG, including no cardiac, pulmonary, hepatic, biliary (except Gilbert's disease, gastrointestinal, or renal (defined as serum creatinine >1.5 mg/dL or a calculated creatinine clearance (CrCl)<50 mL/min), disorders, or cancer within the past 5 years (except localized or in situ cancer of the skin). A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat laboratory evaluation is allowed for eligibility determination.
Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
A female is eligible to enter and participate in this study if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral oophorectomy, hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
Male subjects must agree to use one of the contraception methods listed in the protocol.
Body weight greater than or equal to 50 kg (110 lbs.) for men and greater than or equal to 45 kg (99 lbs.) for women. For Part 1, body mass index (BMI) between 18.5-32 kg/m2 inclusive will be allowed. For Part 3, BMI between 18.5-35.0 kg/m2 inclusive will be allowed.

Key exclusion criteria (16 listed)

Unwillingness or inability to follow the procedures outlined in the protocol.
A positive pre-study test for Human Immunodeficiency Virus (HIV) antibody or Hepatitis B surface antigen.
For healthy subjects in Parts 1 and 2, a positive Hepatitis C antibody result within 3 months of screening. Chronic HCV infected subjects in Part 3 will have a positive HCV antibody and a positive HCV RNA.
Pregnant females as determined by positive serum or urine Human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Subject is mentally or legally incapacitated.

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
GSK2336805 10mgsingle dose once daily	Drug	Part 1: Single Dose Escalation in Healthy Subjects
GSK2336805 30mgsingle dose once daily	Drug	Part 1: Single Dose Escalation in Healthy Subjects
GSK2236805 100mgsingle dose once daily	Drug	Part 1: Single Dose Escalation in Healthy Subjects
GSK2236805 200mgsingle dose once daily	Drug	Part 1: Single Dose Escalation in Healthy Subjects
GSK2236805 10mgrepeat dose once daily for 7 days	Drug	Part 2: Repeat Dose Escalation in Healthy Subjects
GSK2236805 dose to be determined up to 100mgrepeat dose once daily for 7 days	Drug	Part 2: Repeat Dose Escalation in Healthy Subjects
GSK2236805 5mgsingle dose in HCV infected patients	Drug	Part 3: Single Dose Escalation in HCV Infected Subjects
GSK2236805 30mgsingle dose in HCV infected patients	Drug	Part 3: Single Dose Escalation in HCV Infected Subjects
GSK2236805 100mgsingle dose in HCV infected patients	Drug	Part 3: Single Dose Escalation in HCV Infected Subjects

Primary outcome

GSK2336805 safety parameters : adverse events
Time frame: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: telemetry
Time frame: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: absolute values and changes over time of hematology, clinical chemistry, urinalysis
Time frame: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: vital signs (blood pressure, heart rate)
Time frame: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 safety parameters: electrocardiogram (ECG) parameters
Time frame: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days
GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: area under the plasma concentration curve over the dosing interval AUC(0-tau))
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: maximum observed concentration (Cmax)
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: time to maximum observed concentration (tmax)
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: observed concentration at 24h post-dose (C24)
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: terminal half-life (t1/2)
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: lag time (tlag)
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following single dose administration: apparent clearance (CL/F)
Time frame: Part 1 up to 48 hours; Part 2 for 7 and 14 days; Part 3 for 48 hours
GSK2336805 PK parameters following repeat dose administration:AUC(0-tau)
Time frame: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: Pre-dose (trough) concentration at the end of the dosing interval Ctau
Time frame: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: Cmax
Time frame: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: tmax
Time frame: Day 7 and Day 14
GSK2336805 PK parameters following repeat dose administration: t1/2,
Time frame: Day 7 and day 14
GSK2336805 PK parameters following repeat dose administration: CL/F
Time frame: Day 7 and Day 14
GSK2336805 PK parameters following single dose in HCV infected subjects: AUC(0-infinity) or AUC(0 - tau)
Time frame: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: Cmax
Time frame: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: C24
Time frame: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: tmax
Time frame: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: tlag
Time frame: for 48 hours
GSK2336805 PK parameters following single dose in HCV infected subjects: CL/F
Time frame: for 48 hours
HCV Ribonucleic acid (RNA) viral load reduction from baseline during the 24hr and post-dosing following a single dose of GSK2336805 in HCV subjects
Time frame: at baseline, 24 hours, and for 16 days
HCV RNA change from baseline to nadir (maximum change) in HCV subjects
Time frame: baseline, and for 16 days
Time course of HCV viral load at baseline, after dosing with GSK2336805, and for greater than or equal to 2 weeks after GSK2336805 dosing (Part 3)
Time frame: baseline and up to 16 days

12 secondary outcomes

GSK2336805 PK parameters: AUC(0-infinity) or AUC (0 - tau) following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Time frame: 48 hours
GSK2336805 PK parameters: Cmax following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Time frame: 48 hours
GSK2336805 PK parameters: tmax following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Time frame: 48 hours
GSK2336805 PK parameters: tlag following single dose administration of a given dose of GSK2336805 with and without moderate fat/calorie meal (Part 1)
Time frame: 48 hours
GSK2336805 AUC(0-tau) on Day 7 compared to AUC(0-24) on Day 1 to estimate accumulation ratio (R) and GSK2336805 AUC(0-tau) on Day 7 compared to AUC(0-infinity) on Day 1
Time frame: Day 1 and Day 7
Pre-dose concentrations (Ctau) on Day 2 through 7 to assess the achievement of steady state of GSK2336805 following repeat administration (Part 2)
Time frame: Day 2 through Day 7
GSK2336805 PK parameters: AUC(0-infinity), AUC(0-t), Cmax, and C24 following single dose administration
Time frame: 48 hours
GSK2336805 PK parameters: AUC(0-τ), Cτ, and Cmax following repeat administration
Time frame: for 7 days
Correlation between concentration and various safety parameters, if appropriate
Time frame: 16 days
Sequence analysis of the viral quasispecies as appropriate (Part 3).
Time frame: 16 days
GSK2336805 AUC(0-tau) on Day 14 compared to AUC(0-24) on Day 1 to estimate accumulation ratio (R) and GSK2336805 AUC(0-tau) on Day 14 compared to AUC(0-inf) on Day 1
Time frame: 14 days
Pre-dose concentrations (Ctau) on Day 2 through 14 to assess the achievement of steady state of GSK2336805 following repeat administration (Part 2 Cohort E)
Time frame: Day 2 and Day 14

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
Background: PubMed 23896477Wilfret DA, Walker J, Adkison KK, Jones LA, Lou Y, Gan J, Castellino S, Moseley CL, Horton J, de Serres M, Culp A, Goljer I, Spreen W. Safety, tolerability, pharmacokinetics, and antiviral activity of GSK2336805, an inhibitor of hepatitis C virus (HCV) NS5A, in healthy subjects and subjects chronically infected with HCV genotype 1. Antimicrob Agents Chemother. 2013 Oct;57(10):5037-44. doi: 10.1128/AAC.00910-13. Epub 2013 Jul 29.
Results for study 114885 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

3 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 GSK2336805 10mg, GSK2336805 30mg and GSK2236805 100mg in people with Hepatitis C, run by GlaxoSmithKline at 3 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 14 inclusion and 16 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

GSK2336805 safety parameters : adverse events (time frame: Part 1 change from baseline for 14 days; Part 2 change from baseline for 24 days; Part 3 change from baseline for 16 days). The study lists 28 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 NCT01277692, which also lists 1 linked publication.

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 28 Jun 2017.