Hepatitis CPhase 1NCT01332552
A First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2485852 in Chronically Infected Hepatitis C Subjects
A Phase 1 study testing GSK2485852 70 mg, GSK2485852 420 mg and GSK2485852 630 mg in people with Hepatitis C, run by GlaxoSmithKline at 5 sites in United States.
Trial summary
GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed for the treatment of chronic HCV infection. HBI115040 is the first administration of GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and antiviral profile. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- GSK2485852 70 mg, GSK2485852 420 mg and GSK2485852 630 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Jan 2011to 6 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply: Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring (i.e., ECG), including no cardiac, pulmonary, hepatic, biliary, gastrointestinal, or renal disorders, or cancer within the past 5 years.
- Males or females between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of non-childbearing potential.
- Body weight > or = 50 kg (110 lbs.) for men and > or = 45 kg (99 lbs.) for women and BMI between 18.5-35.0 kg/m2 inclusive will be allowed.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- AST, ALT, and alkaline phosphatase <3.0xULN and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
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- Average QTcB or QTcF < 450 msec; or QTcB or QTcF < 480 msec in subjects with Bundle Branch Block.
- Treatment naive chronically infected HCV subjects, defined as infection for >6 months and no prior HCV therapy, with an HCV RNA viral load of greater than 100,000 IU/mL and HCV genotype 1a or 1b. HCV subjects with mixed genotypes are not eligible for the study.
- Positive for HCV RNA and anti-HCV antibody at the time of screening AND positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening; OR Positive for HCV RNA and anti-HCV antibody at the time of screening AND liver biopsy within three years prior to screening indicating the absence of cirrhosis.
Who cannot join
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- A positive pre-study Hepatitis B surface antigen or HIV antibody within 3 months of screening.
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
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- 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 products within 12 months prior to the first dosing day.
- 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,
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- 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, SVT (>10 consecutive beats)); Sustained tachycardia >150 beats per minute; 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, AV block [2nd degree or higher in an awake subject], 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 ECG changes that include flat or downsloping 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Las Vegas, Nevada, 89106
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
Willingboro, New Jersey, 08046
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 GSK2485852 in Chronically Infected Hepatitis C Subjects
GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed for the treatment of chronic HCV infection. HBI115040 is the first administration of GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and antiviral profile. The study design is a fusion of single and repeat dosing cohorts in HCV infected subjects to evaluate the safety, pharmacokinetics, and antiviral activity of GSK2485852.
HBI115040 describes a Phase I, randomized, double-blind, placebo-controlled, dose escalation fusion study to determine the safety, tolerability, pharmacokinetic, and antiviral profile of GSK2485852 in single doses (Part 1), repeat doses (Part 2), and ritonavir co-administration (Part 3) in chronically infected HCV subjects. The study will also explore the effect of a moderate (30%) fat meal on pharmacokinetic endpoints in HCV subjects in Part 1.
- Conditions
- Hepatitis C
- Being tested
- GSK2485852 70 mg, GSK2485852 420 mg, placebo, GSK2485852 630 mg, GSK2485852 70 mg + Ritonavir 100mg
- Keywords
- pharmacokinetics, First administration to human, antiviral activity, safety, hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2485852 70 mgDrug
single dose
GSK2485852 420 mgDrug
single dose
placeboDrug
single dose
placeboDrug
Repeat dose, once daily for 3 days
GSK2485852 420 mgDrug
Repeat dose, twice daily for 3 days
GSK2485852 420 mgDrug
Repeat dose, TIDfor 3 days
GSK2485852 630 mgDrug
Repeat dose, twice daily for 3 days
GSK2485852 70 mg + Ritonavir 100mgDrug
single dose, day 1
GSK2485852 210 mg + Ritonavir 100mgDrug
single dose, day 1
GSK2485852 210 mg +Ritonavir 100mgDrug
single dose daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single dose escalation | Experimental | GSK2485852 planned single doses are placebo, 70 mg, 420 mg, 70 mg with food Receives: Drug: GSK2485852 70 mg; Drug: GSK2485852 420 mg; Drug: placebo; Drug: GSK2485852 70 mg + Ritonavir 100mg |
| Part 2: Repeat dose escalation | Experimental | GSK2485852 planned repeat doses are placebo, 420mg BID, 420mg TID, 630mg BID Receives: Drug: placebo; Drug: GSK2485852 420 mg; Drug: GSK2485852 630 mg; Drug: GSK2485852 210 mg + Ritonavir 100mg |
| Part 3: GSK2485852 + Ritonavir | Experimental | GSK2485852 single dose 70mg, 210 mg +Ritonavir 100mg x 1 day; GSK2485852 210mg + Ritonavir 100mg single dose x 3 days; Receives: Drug: GSK2485852 210 mg +Ritonavir 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters: adverse events; telemetry; absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs (blood pressure, heart rate), and electrocardiogram (ECG) parameters
Measured: up to 7 days
GSK2485852 PK parameters following single dose administration: AUC(0-inf), AUC(0-t), AUC(0-24), Cmax, tmax, C24, t1/2, tlag, and CL/F
Measured: 24 hours
GSK2485852 PK parameters following repeat dose administration: AUC(0-τ), Cτ, Cmax, tmax, t1/2, and CL/F
Measured: 72 hours
HCV RNA viral load reduction from baseline
Measured: 24 to 72 h
HCV RNA change from baseline to nadir
Measured: up to 72 h
Time course of HCV viral load at baseline, during dosing with GSK2485852, and > or = 14 days after GSK2485852 dosing
Measured: up to 14 days
Secondary outcomes (4)
GSK2485852 PK parameters: AUC(0-24), Cmax, tmax and tlag following a single dose with and without moderate fat/calorie meal.
Measured: 24 h
GSK2485852 accumulation ratio (R)
Measured: 72 h
GSK2485852 time invariance in non-food cohorts
Measured: 72 hours
GSK2485852 dose proportionality after single or repeat dosing in non-food cohorts
Measured: up to 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study start14 Jan 2011
- Primary completion6 Apr 2011
- Study completion6 Apr 2011
Why it stopped: Terminated due to unfavorable human pharmacokinetic properties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332552
- Sponsor's protocol ID
- 115040
- Status last verified
- Jul 2017
- First submitted
- 7 Apr 2011
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 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 GSK2485852 in Chronically Infected Hepatitis C Subjects
- ClinicalTrials.gov ID
- NCT01332552
- Acronym / sponsor ID
- 115040
- Conditions
- Hepatitis C
- Keywords
- pharmacokinetics, First administration to human, antiviral activity, safety, hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to unfavorable human pharmacokinetic properties
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2011 (actual)
- Primary completion
- 6 Apr 2011 (actual)
- Study completion
- 6 Apr 2011 (actual)
- First posted
- 11 Apr 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.
GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed for the treatment of chronic HCV infection. HBI115040 is the first administration of GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and antiviral profile. The study design is a fusion of single and repeat dosing cohorts in HCV infected subjects to evaluate the safety, pharmacokinetics, and antiviral activity of GSK2485852.
HBI115040 describes a Phase I, randomized, double-blind, placebo-controlled, dose escalation fusion study to determine the safety, tolerability, pharmacokinetic, and antiviral profile of GSK2485852 in single doses (Part 1), repeat doses (Part 2), and ritonavir co-administration (Part 3) in chronically infected HCV subjects. The study will also explore the effect of a moderate (30%) fat meal on pharmacokinetic endpoints in HCV subjects in Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single dose escalation | Experimental | Drug: GSK2485852 70 mg, Drug: GSK2485852 420 mg, Drug: placebo, Drug: GSK2485852 70 mg + Ritonavir 100mgGSK2485852 planned single doses are placebo, 70 mg, 420 mg, 70 mg with food |
| Part 2: Repeat dose escalation | Experimental | Drug: placebo, Drug: GSK2485852 420 mg, Drug: GSK2485852 630 mg, Drug: GSK2485852 210 mg + Ritonavir 100mgGSK2485852 planned repeat doses are placebo, 420mg BID, 420mg TID, 630mg BID |
| Part 3: GSK2485852 + Ritonavir | Experimental | Drug: GSK2485852 210 mg +Ritonavir 100mgGSK2485852 single dose 70mg, 210 mg +Ritonavir 100mg x 1 day; GSK2485852 210mg + Ritonavir 100mg single dose x 3 days; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply: Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring (i.e., ECG), including no cardiac, pulmonary, hepatic, biliary, gastrointestinal, or renal disorders, or cancer within the past 5 years.
- Males or females between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of non-childbearing potential.
- Body weight > or = 50 kg (110 lbs.) for men and > or = 45 kg (99 lbs.) for women and BMI between 18.5-35.0 kg/m2 inclusive will be allowed.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (12 listed)
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- A positive pre-study Hepatitis B surface antigen or HIV antibody within 3 months of screening.
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study.
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 |
|---|---|---|
| GSK2485852 70 mgsingle dose | Drug | Part 1: Single dose escalation |
| GSK2485852 420 mgsingle dose | Drug | Part 1: Single dose escalation |
| placebosingle dose | Drug | Part 1: Single dose escalation |
| placeboRepeat dose, once daily for 3 days | Drug | Part 2: Repeat dose escalation |
| GSK2485852 420 mgRepeat dose, twice daily for 3 days | Drug | Part 2: Repeat dose escalation |
| GSK2485852 420 mgRepeat dose, TIDfor 3 days | Drug | Part 2: Repeat dose escalation |
| GSK2485852 630 mgRepeat dose, twice daily for 3 days | Drug | Part 2: Repeat dose escalation |
| GSK2485852 70 mg + Ritonavir 100mgsingle dose, day 1 | Drug | Part 1: Single dose escalation |
| GSK2485852 210 mg + Ritonavir 100mgsingle dose, day 1 | Drug | Part 2: Repeat dose escalation |
| GSK2485852 210 mg +Ritonavir 100mgsingle dose daily for 3 days | Drug | Part 3: GSK2485852 + Ritonavir |
Primary outcome
Safety parameters: adverse events; telemetry; absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs (blood pressure, heart rate), and electrocardiogram (ECG) parameters
Time frame: up to 7 days
GSK2485852 PK parameters following single dose administration: AUC(0-inf), AUC(0-t), AUC(0-24), Cmax, tmax, C24, t1/2, tlag, and CL/F
Time frame: 24 hours
GSK2485852 PK parameters following repeat dose administration: AUC(0-τ), Cτ, Cmax, tmax, t1/2, and CL/F
Time frame: 72 hours
HCV RNA viral load reduction from baseline
Time frame: 24 to 72 h
HCV RNA change from baseline to nadir
Time frame: up to 72 h
Time course of HCV viral load at baseline, during dosing with GSK2485852, and > or = 14 days after GSK2485852 dosing
Time frame: up to 14 days
4 secondary outcomes
GSK2485852 PK parameters: AUC(0-24), Cmax, tmax and tlag following a single dose with and without moderate fat/calorie meal.
Time frame: 24 h
GSK2485852 accumulation ratio (R)
Time frame: 72 h
GSK2485852 time invariance in non-food cohorts
Time frame: 72 hours
GSK2485852 dose proportionality after single or repeat dosing in non-food cohorts
Time frame: up to 72 h
Results and safety
The study was stopped early (reason given: Terminated due to unfavorable human pharmacokinetic properties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 115040 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
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 GSK2485852 70 mg, GSK2485852 420 mg and GSK2485852 630 mg in people with Hepatitis C, run by GlaxoSmithKline 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 7 Jul 2017. 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?
The study was stopped early (reason given: Terminated due to unfavorable human pharmacokinetic properties). Results are not available in the source record.
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?
Safety parameters: adverse events; telemetry; absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs (blood pressure, heart rate), and electrocardiogram (ECG) parameters (time frame: up to 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.